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Trials
ECOG 1105: A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-expressing Metastatic Breast Cancer
This randomized phase III trial is studying first-line chemotherapy and trastuz…
This randomized phase III trial is studying first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.
Gradishar, William JGradishar, William J
NCT00520975 STU00003529
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1 312 695 1102
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NU 05H6: Acute Leukemias and Map Kinase

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the prod…

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells. 

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), which are cancers of the blood that affect white blood cells. 

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00004841
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Study Coordinator 312 695 1102
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NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) ti…

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research. 

You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas. 

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
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Study Coordinator 312 695 1102
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NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be…
Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. 

This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

You may be eligible for this research study if you have unresectable cancer primarily in the liver (with the liver being the only site of disease or the dominant site of disease).
Salem, RiadSalem, Riad
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00530010 STU00011036
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Study Coordinator 1 312 695 1102
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A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells m…

Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. 

This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.

You may be eligible for this research study if you have been diagnosed with metastatic disease to the liver. This means your cancer originated from somewhere else in your body and spread to your liver. 

You cannot be eligible to have surgery to remove the cancerous tissue from your liver.

Salem, RiadSalem, Riad
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00532740 STU00011037
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Study Coordinator 312 695 1102
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NU 09B2: Case Control Study of Biomarkers of Breast Cancer Risk in Benign Biopsy Samples

This study is being conducted to better understand the causes of breast cancer. Currently, our ability to determine if a particular woman is at higher than average risk for breast cancer is only a little bette…

This study is being conducted to better understand the causes of breast cancer. Currently, our ability to determine if a particular woman is at higher than average risk for breast cancer is only a little better than flipping a coin. However, there is good reason to believe that we can obtain much more information by focusing directly on breast cells and looking at the biochemical changes that predate cancer. We expect that breast cells present in breast biopsy samples will be a practical place to look for such changes, and that this will help us to predict which women will get breast cancer. In the future, we could then focus on high risk women to offer them methods of breast cancer prevention and also to target them for early diagnosis. It may also mean that we could spare women who are at low risk for breast cancer from treatment that may have side effects, and from unnecessary testing or surgery. The breast tissue changes we will look for may involve alterations in genes or in proteins. If we find changes in genes in the breast, these may be harmless variations (like genes that explain eye color or height), or they may be harmful, possibly promoting the development of cancer. To tell whether the changes were acquired only in the breast, later in life, or whether you were born with them, we will need to compare the breast genes with your bloodline genes. We can do this by collecting a sample of saliva.

You may be eligible for this research study if you have had breast surgery in the past for either a benign breast problem or breast cancer. 

Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00013577
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Study Coordinator 1 312 695 1102
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NU 00X3: Pathology Core Facility

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized r…

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for the research community. The samples collected can be used by researchers at Northwestern University and third party commercial and non-profit institutions who have approval from their Institutional Review Board (a committee which is responsible for the ethical oversight of the study) for their projects. 

You will be asked to donate a sample of blood. In addition, any extra tissue or fluid from what has been collected from you for your routine care will be used. Examples of samples include but are not limited to tissue, blood, urine, and bone marrow. 

Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00020989
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Study Coordinator 1 312 695 1102
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RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pacli…
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Some of the eligibility criteria include:

- Participants must be 18 years old or older.
- Participants must have undergone radical hysterectomy prior to entering the study.
- Participants cannot be allergic to carboplatin, paclitaxel and/ or cisplatin.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
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Study Coordinator 312 695 1102
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NU 01CC4: STAR (Survivors Taking Action and Responsibility)

The goal of this program is to collect data reflecting past and current medical and behavioral issues related to diagnosis and treatment of childhood cancer. Much is known about the impact up to ten years after cure, but the long-term eff…

The goal of this program is to collect data reflecting past and current medical and behavioral issues related to diagnosis and treatment of childhood cancer. Much is known about the impact up to ten years after cure, but the long-term effects of the cancer and treatments must be better understood to help both you and future survivors.

You may be eligible for this research study if you are a survivor of childhood cancer. 
Didwania, AaratiDidwania, Aarati
  • Map it 201 E. Huron St.
    Chicago, IL
STU00029383
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Study Coordinator 312 695 1102
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NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods …
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Shulman, Lee PShulman, Lee P
NCT00005095 STU00005421
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1-855-NU-STUDY
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NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a…

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only. 

Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease). 

You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00023488
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Study Coordinator 1 312 695 1102
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NCI 02H2: Signal Transduction of Type I Interferons in Malignant Cells

This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (E…

This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.

You may be eligible for this research study if you have been diagnosed with a group of diseases called myeloproliferative neoplasms (MPN) and are already scheduled to have

blood and bone marrow samples taken for routine health monitoring purposes.

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00006780
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Study Coordinator 312 695 1102
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Peripheral Neuropathy Research Registry (PNRR)
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in t…
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in the future. The registry aims to help researchers’ access large amounts of information about people with PN. By using this registry, researchers will facilitate both basic and clinical research studies that will bring improved understandings of the etiology (origination) and pathogenesis (development) of PN. They will specifically ask why some patients with peripheral neuropathy develop neuropathic pain and others do not, and what the characteristics of patients with painful peripheral neuropathy are in terms of their symptoms, examination findings, and blood tests. Ultimately this research may result in improved diagnosis, more effective treatments, and possibly prevention.
Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00048864
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Joslin, Benjamin 312 503 7504
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NU 11B04: Breast Tissue Biomarkers of ER- Specific Cancer Risk that Are Valid Across Menstrual and Menopausal Status

The purpose of this study is to discover predictors of future cancer in the healthy tissue of the opposite breast as compared to tissue from women with no breast disease. 

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The purpose of this study is to discover predictors of future cancer in the healthy tissue of the opposite breast as compared to tissue from women with no breast disease. 

If you participate in this study and are having a preventive mastectomy, no extra tissue will be removed for this study. If you are not having a preventive mastectomy, we will perform a needle biopsy of your other breast for research purposes. If you do not have breast cancer, we will use a portion of the healthy tissue removed during your reduction or augmentation surgery for research.

You may be eligible for this research study if you fit into one of the following categories:

1. You have been diagnosed with breast cancer and you and your doctor have decided that you will benefit from a preventive mastectomy of your other (non-cancerous) breast, OR

2. You have been diagnosed with breast cancer on one side and will soon be having surgical or medical treatment for that cancer, OR

3. You have no evidence of breast disease and are scheduled to undergo either a breast reduction or breast augmentation surgery.

Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00051134
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Study Coordinator 1 312 695 1102
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NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect …

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00039629
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Study Coordinator 312 695 1102
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A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well …
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
Dokucu, Mehmet EDokucu, Mehmet E
NCT01701284 STU00063218
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Fairchild, Melody Dawn 312 503 7071
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The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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Khawaja, Faizan 312 694 2417
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Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal …
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal therapy, and how these brain areas are related to the development of mild cognitive impairment as the results of these treatments. This study involves obtaining pictures of the brain’s size, shape and activity using a Magnetic Resonance Imaging (MRI) device, a machine that uses a powerful magnet to obtain this information without using any radiation. This procedure has been used safely with humans in many different studies. Your part in this study will last for 1 to 2 years.
Female breast cancer patients between 40-70 years old
Wang, LeiWang, Lei
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT01949376 STU00069634
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Fairchild, Melody Dawn +1 312 503 7071
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NCI 12H13: The Role of ICSBP in the Pathogenesis of Chronic Myeloid Leukemia

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The p…

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future. 

You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00074258
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Study Coordinator 312 695 1102
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NU 12G11: The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tiv…
This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Matei, DanielaMatei, Daniela
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01853644 STU00073756
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Study Coordinator 312 695 1102
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RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01872975 STU00083782
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Study Coordinator 312 695 1102
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NU 13S02: Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is fo…
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02048722 STU00087654
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Study Coordinator 312 695 1102
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NUDB 13C03: Northwestern Brain Tumor Institute Research Database

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain add…

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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Study Coordinator 1 312 695 1102
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Epigenetic Markers of Bladder Cancer Progression
The purpose of this study is to better understand the expression of certain genes and genetic changes that occur in bladder tumors.
Male or female patients aged 40-89 identified to have a bladder lesion or mass concerning for urothelial carcinoma based on cystoscopy or imaging who are scheduled to undergo transurethral resection of bladder tumor (TURBT).
Meeks, Joshua JMeeks, Joshua J
STU00088853
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Meeks, Joshua J 312 695 8146
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A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
This study is a prospective Phase IV study to determine if the …
This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Kulik, Laura MKulik, Laura M
NCT02081755 STU00083409
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Bezler, Laura 312 694 0260
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B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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Wolfe, Kaitlin A 312 503 3248
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DRUG ATI001-102: A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
This research study involves two investigational drugs…
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02026271 STU00094296
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Amidei, Christina 312 695 9124
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ECOG 1910: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults.
Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview …
Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview This study is for patients who have recently been diagnosed with a subtype of ALL that is known as BCR-ABL negative B-lineage ALL. Blinatumomab is a new antibody therapy that binds to B cells and recruits T cells to attack leukemia B cells. Patients will be randomized to receive chemotherapy what has traditionally been used to treat this sub-type of ALL alone or chemotherapy with blinatumomab . Studies are being done in ALL and other blood cancers with blinotumomab Blinatumomab has been effective in residual or relapsed B-cell ALL at destroying these specific cells. But it has not yet been proven helpful in combination with chemotherapy in newly diagnosed ALL. Description of Treatment There are several steps of treatment in this study. They are called induction, intensification, consolidation, and maintenance. In these study steps participants will be getting standard chemotherapy treatments that may or may not be combined with a new cancer drug called blinatumomab. Blinatumomab is a drug that is given as a continues infusion. The treatment schedule should be discussed with the study doctor.
Some of the eligibility criteria include:

- Participants in this study must have B lineage ALL that is Philadelphia chromosome and BCR/ABL negative. Please discuss this requirement with the study doctor.
- Participants must be 35-70 years old.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Dinner, ShiraDinner, Shira
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02003222 STU00093458
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Study Coordinator 312 695 1102
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NU 14H04: Phase II Study of Romidepsin plus Lenalidomide for Patients with Previously Untreated PTCL
The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymp…
The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).
Some of the eligibility criteria include:

- Participants must have PTCL.
- Participants may not have had prior systemic treatment for their PTCL. Treatment with corticosteroids is allowed. Please discuss all treatments with the study doctor.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Pro, BarbaraPro, Barbara
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02232516 STU00097620
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Study Coordinator 312 695 1102
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Development of a Kidney Cancer Patient Outcomes Database
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who …
Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter information about their disease, treatment, symptoms, health status, and quality of life into an on-line, password-protected database on a regularly scheduled basis. Participants can use the registry to track many of their symptoms and their health status over time and to compare themselves (anonymously) with other groups of people (for example, how their level of fatigue compares with the average level of fatigue reported by other participants in the registry). Participants can also choose to share relevant information about themselves (from the registry) with their health care provider(s), by printing copies of their completed forms. Registry participants will be offered opportunities to join in other research studies when available. Description of Treatment Participants in this study will be asked to do the following for a 1-year trial period: 1) enroll in the on-line registry; 2) complete questionnaires about their health and treatment every 3 months ; and 3) be willing to have MYQOL researchers contact them confidentially about participating in other research studies. This does not mean that participants are obligated to participate in future research studies; only that they agree to be contacted.
Some of the eligibility criteria include:

- Participants must have a kidney cancer diagnosis.
- Participants must be 18 or older.
- Participants must be able to read English well enough to complete questionnaires.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cella, DavidCella, David
  • Map it 201 E. Huron St.
    Chicago, IL
STU00070200
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Study Coordinator 312 695 1102
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A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

This randomized phase III trial studies how well the study drug (crizotinib, also known …

This randomized phase III trial studies how well the study drug (crizotinib, also known as XALKORI®) works, and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. 

It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK mutation. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach.

The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib will be prescribed for earlier stage disease after the cancer has been surgically removed.

You are being asked to take part in this research study because you have ALK-positive non-small cell lung cancer, which has been removed by a surgeon. 
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02201992 STU00102000
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Study Coordinator 312 695 1102
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Behavioral activation and varenicline for smoking cessation in depressed smokers
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Beh…
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Behavioral activation for smoking cessation + placebo; 3) Standard behavior therapy + varenicline (Chantix); or 4) Behavioral activation for smoking cessation + varenicline (Chantix).
1. Adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
2. Lifetime history of clinical depression (Major Depressive Disorder)
Hitsman, Brian LHitsman, Brian L
NCT02378714 STU00100303
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Reyes, Celine 1 877 236 7487
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Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying…

This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. The purpose of the study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes. 

Genetic testing will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is your unique genetic material that carries the instructions for your body’s development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.

Another purpose of this research study is to learn more about cancer and why treatments may be more effective or even stop working with some tumors or in certain patients. After your tumor tissue is screened, if there is any tissue left, the remainder of your coded tissue samples will be sent to a National Cancer Institute (NCI)-sponsored storage facility, currently known as the Biospecimen Core Resource (BCR).

You may be eligible for this research study if you have lung cancer that has either been removed or will be removed by a surgeon. As part of your normal treatment, you may receive chemotherapy or radiation therapy to reduce the chance of the cancer coming back.

Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02194738 STU00200150
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Study Coordinator 312 695 1102
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RTOG 1216: Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

This randomized phase III trial studies how well radiation therapy works when …

This randomized phase III trial studies how well radiation therapy works when given together with cisplatin compared to with docetaxel or cetuximab and docetaxel after surgery in treating patients with squamous cell head and neck cancer. 

The purpose of this study is to compare the effects, good and/or bad, of the standard treatment (radiation therapy and cisplatin) with a chosen experimental treatment (either radiation therapy and docetaxel, or radiation therapy, cetuximab, and docetaxel) to find out which is a better treatment for head and neck cancer. Subjects will get either the standard treatment or the experimental treatment.

Cisplatin and docetaxel are standard chemotherapy drugs. They work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 

Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that affects cancer growth and many other functions.

Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 

It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

You may be eligible for this research study if you have head and neck cancer.
Mittal, Bharat BMittal, Bharat B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01810913 STU00200314
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Study Coordinator 312 695 1102
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NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
There are two study questions the investigators are asking in this randomized phase II/III trial b…
There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Mittal, Bharat BMittal, Bharat B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02135042 STU00200330
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Study Coordinator 312 695 1102
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NU 14S03: A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The…
The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The safety of this drug combination will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02357810 STU00200112
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Study Coordinator 312 695 1102
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Alliance A081105: Randomized Study of Erlotinib vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Purpose The purpose of this study is to compare any good and bad effects patients may have when treated with the st…
Purpose The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). Overview This study is for patients with early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). Researchers are trying to find out if this mutation could help doctors make decisions about which type of treatment is best for people with this type of cancer. People not in a research study are usually not treated with anything after they finish their chemotherapy although some of them may receive radiation therapy. Description of Treatment This study has two study groups. Group 1 will get the study drug called erlotinib. The erlotinib will be taken once a day. Group 2 will get the placebo, which looks just like the erlotinib but does not have any active ingredients. The placebo will be taken once a day.
Some of the eligibility criteria include:

- Participants must have NSCLC.
- Participants must EGFR mutant and ALK rearrangement, which is detected by genetic testing performed through the study doctor's office.
- Participants must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02193282 STU00200145
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Study Coordinator 312 695 1102
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Ex vivo interactions between high-density-like nanoparticles and human blood
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Pr…
This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an in-depth knowledge of the interaction of the HDL-NPs with human blood cells using safe ex vivo experiments.
Healthy, non-pregnant adult (age >18-75 years) volunteers.
Thaxton, Colby SThaxton, Colby S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200368
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Thaxton, Colby S 312 503 1826
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NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a proble…

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future. 

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study. 

You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood.

Eklund, Elizabeth AEklund, Elizabeth A
  • Map it 201 E. Huron St.
    Chicago, IL
STU00200435
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Study Coordinator 312 695 1102
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A Phase 3 Multicenter, Randomized, Placebo-Controlled Study to Determine the Efficacy of Topical SGX301 and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
To evaluate the safety and effectiveness of the topical ointment (cream), SGX301, in combination with light the…
To evaluate the safety and effectiveness of the topical ointment (cream), SGX301, in combination with light therapy in patients with cutaneous T-cell lymphoma.
Must be 18 years of age or older, with a clinical diagnosis of Cutaneous T- Cell Lymphoma, Myucosis Fungoides, Stage IA. Stage IB, or Stage IIA, and willing to refrain from sunbathing for duration of the study.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02448381 STU00200530
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Jimenez, Javier 312 503 5903
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NU 14H09: A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients with MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen
The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it…
The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.
Some of the eligibility criteria include:

- Participants must have diffuse large B-cell lymphoma (DLBCL) or other aggressive B-cell lymphoma that has an MYC-rearrangement. This is determined with special laboratory testing.
- Participants may not have had more than one prior cycle of chemoimmunotherapy for their lymphoma. All treatments should be discussed with the study doctor.
- Participants must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Pro, BarbaraPro, Barbara
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02481310 STU00200596
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Study Coordinator 312 695 1102
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A Prospective Study of Early Stage Breast Cancer Patients with Abnormal Myocardial Deformation treated with Anthracycline and/or Trastuzumab and Pertuzumab-based cancer therapy.
This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV funct…
This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV function, will prevent a worsening of strain, allowing patients to stay on their chemotherapy treatment.

Main Inclusion:

  • Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I – III)
  • Pathology report must include HER2 expression, estrogen and progesterone receptor status
  • Normal LV function (EF > 53%) on baseline echocardiogram
  • NYHA functional class I-II
  • Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens

Main Exclusion:

  • Pre-existing cardiac disease (moderate-severe coronary artery disease, moderate-severe valvular heart disease, constrictive/restrictive cardiomyopathies)
  • Metastatic breast cancer
  • Prior use of BB/ACE therapy
  • 2nd and 3rd degree AV block, Sick Sinus Syndrome, severe bradycardia (<50 BPM), or severe hypotension (SBP < 85 mmHg)
  • Severe liver dysfunction or moderate-severe asthma
Akhter, NausheenAkhter, Nausheen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02993198 STU00200675
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Ramirez, Haydee +1 312 695 2928
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ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

The main purpose of this study is to compare getting more treatment with capecitabine (i.e. on…

The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery.

Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV (i.e., metastatic) breast cancers, but are usually not used in patients with early forms of breast cancer. Getting a platinum-based chemotherapy after surgery could reduce the risk of cancer returning (metastatic recurrence) in the breast or at other distant organs, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than using capecitabine chemotherapy. 

You may be eligible for this research study if you:

  • Have early stage breast cancer. 
  • Have a breast cancer that does not have the estrogen, progesterone or HER2 receptor, and is called triple-negative breast cancer.
  • Have completed all your chemotherapy prior to your surgery.
  • Had ≥ 1 cm worth of cancer in the breast at the time of your surgery.

Flaum, LisaFlaum, Lisa
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02445391 STU00201173
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Study Coordinator 312 695 1102
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NU 15B01: A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort

The main purpose of this study is to determine the anti-tumor activity of durvalumab (ME…

The main purpose of this study is to determine the anti-tumor activity of durvalumab (MEDI4736) in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. 

Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by binding to a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.

Both durvalumab and tremelimumab are “investigational” drugs, which means that the drugs are not approved by the Food and Drug Administration. The idea behind developing these types of experimental drugs is that stimulating the immune system could be a different way of killing cancer cells.

We will be investigating primarily the ability of this drug combination to shrink tumors, or prevent them from growing larger. We will also investigate if this drug combination can increase survival. Finally, we will explore how these drugs affect your immune system and tumor cells by conducting tests on tumor samples before and after the first two months of treatment. This will help us learn if certain types of tumor or immune system features are associated with better responses. The information learned in this study may be helpful in the further development of durvalumab and tremelimumab for the treatment of women with advanced breast cancer.

You may be eligible for this research study if you have metastatic breast cancer that has not responded to or stopped responding to at least one line of standard-of-care chemotherapy.

Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02536794 STU00200984
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Study Coordinator 312 695 1102
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x(CIRB) NRG-BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
This randomized phase II/III trial studies how well standard of care therapy with stereotac…
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
Strauss, Jonathan BStrauss, Jonathan B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02364557 STU00201769
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Study Coordinator 312 695 1102
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SMART Weight Loss Management
SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss…
SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss and best follow-up approach for those who need more support from a weight loss program
You are between the ages of 18 - 60 years old.
You will live in the Chicagoland area for the next 12 months.
You are NOT currently pregnant, trying to become pregnant, or breastfeeding.
You do NOT have an unstable medical condition.
You own an Android or iPhone smartphone.
You are willing to track your lifestyle behaviors using a smartphone for 3 months.
Spring, BonnieSpring, Bonnie
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
NCT02997943 STU00202075
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Scanlan, Laura 312 503 1395
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Sense2Stop: Mobile Sensor Data to Knowledge
Sense2Stop is a 15-day smokingcessation research study that involves answering surveys on a study-providedsmartphone, smoking cessation counseling, 3 in-person lab sessions, andwearable sensors to detect smoking, eating, and stress. The aim of this res…
Sense2Stop is a 15-day smokingcessation research study that involves answering surveys on a study-providedsmartphone, smoking cessation counseling, 3 in-person lab sessions, andwearable sensors to detect smoking, eating, and stress. The aim of this research is to build systems that can recognize when peopleare stressed and then provide them with relaxation prompts in the moment toreduce their likelihood of being stressed, smoking, or overeating in the nearfuture. Using these systems should help smokers be more effective in theirattempts to quit by reducing their tendency to lapse when they are stressed orexperiencing other negative moods or behaviors.
-Age: 18 to 65 years old ; Smokes 1+ cigarettes/day for past year. ; Willing to try to quit smoking for at least 48 hours during a 15-day quit trial. ; Will not use non-cigarette tobacco products or nicotine replacement
therapy during the study period ; Not taking or intending to take pharmacological smoking cessation aids
(e.g., nicotine replacement, bupropion, venlafaxene) during the study
period
Spring, BonnieSpring, Bonnie
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03184389 STU00201566
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Daly, Elyse 312 503 1317
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A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxife…
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Some of the eligibility criteria include:

- Participants must be postmenopausal women with newly diagnosed DCIS scheduled to undergo surgical therapy.
- Patients must be able to swallow the oral medication.
- Patients must be able to understand and the willing to sign a written informed consent document and comply to all procedures.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kulkarni, SwatiKulkarni, Swati
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02694809 STU00202100
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Study Coordinator 312 695 1102
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NU 15N01: Head and Neck Tissue Bank

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be a…

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

Matsangou, MariaMatsangou, Maria
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202177
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Study Coordinator 312 695 1102
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The Role of Hormone Receptors in Breast Cancer Development in BRCA1/2 Mutation Carriers

The purpose of this research study is to determine how the hormones estrogen, progesterone, and cortisone may work through their receptor proteins to help breast cancers to develop in women with BRCA1 and BRCA2…

The purpose of this research study is to determine how the hormones estrogen, progesterone, and cortisone may work through their receptor proteins to help breast cancers to develop in women with BRCA1 and BRCA2 mutations. At the moment, the only proven way to prevent breast cancer for women with BRCA mutations is bilateral mastectomy (removal of both breasts). In this study, we will test the effects of selective hormone receptor modulators on breast cells derived from BRCA1 and BRCA2 mutation carriers. If this works in the way we think it will, we may then be able to develop new ways of preventing cancers in BRCA mutation carriers.

Participation will consist of a one-time questionnaire, blood draw, and tissue collection at the time of your scheduled surgery.

You may be eligible for this research study if you fit into one of the following categories: 

1) you have been diagnosed with breast cancer and you and your doctor have decided that you will benefit from a preventive mastectomy of your other (non-cancerous) breast, or 

2) you are a BRCA1 or BRCA2 mutation carrier with no evidence of breast cancer and are scheduled to undergo a preventive mastectomy of both breasts, or 

3) you have no evidence of breast disease and are scheduled to undergo breast reduction surgery.

Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202331
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Study Coordinator 1 312 695 1102
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NU 15N02: Northwestern Head and Neck Cancer Registry

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct…

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck. 

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202162
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Study Coordinator 312 695 1102
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NU 15B08: A Phase II Single Arm Study of Palbociclib in Patients with Metastatic HER2-positive Breast Cancer with Brain Metastasis
Purpose The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to d…
Purpose The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to determine the overall radiographic response rate in the CNS. Overview Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as triple negative and HER2 positive breast cancer. The study drug palbociclib is a small molecule and can penetrate the meninges. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have triple negative and HER2-positive breast cancer. Description of Treatment All study participants will get the study drug in the form of a pill that will be taken once a day for 21 days followed by a 7 day break. These 28 days is considered as one cycle. The participants with HER2-positive breast cancer may also receive trastuzumab (standard of care) concurrently.
Some of the eligibility criteria include:

- Participants who have been diagnosed with triple negative or HER2-positive metastatic breast cancer.
- Participants must have been treated previously with more than two lines of chemotherapy for metastatic disease.
- Participants must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02774681 STU00202582
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Study Coordinator 312 695 1102
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DRUG C-500-01: A Phase 1 Open-label, Multicenter Study To Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884), and to Estimate the Maximum Tolerated Dose in Subjects With Advanced or Refractory Cancer

This study will be testing a thera…

This study will be testing a therapy called AGEN1884, an immune therapy that targets the immune cells to block a protein called CTLA-4. This therapy is designed to improve the ability of the immune system to fight your cancer. 

The FDA (the U.S. Food and Drug Administration) has not approved AGEN1884 as a treatment for any disease. This is the first time that AGEN1884 will be given to humans.

The purpose of the study is to evaluate the safety of AGEN1884 and determine the most appropriate dose for use in future studies.

You may be eligible for this research study if you have advanced cancer.

You have already been treated with other therapies that are commonly used for your cancer, and your cancer has recurred or not responded to those treatments.

Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02694822 STU00202198
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Study Coordinator 312 695 1102
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Alliance A091302: Randomized phase II study of sorafenib with or without everolimus in patients with radioactive iodine refractory Hürthle cell thyroid cancer

The purpose of this study is to compare any good and bad effects of using everolimus along with sorafenib versus sorafenib alone in treat…

The purpose of this study is to compare any good and bad effects of using everolimus along with sorafenib versus sorafenib alone in treating patients with advanced radioactive iodine refractory thyroid cancer. The addition of everolimus to the usual sorafenib might cause more shrinkage of the cancer and might prevent it from growing but it could also cause more side effects than sorafenib alone. This study will allow the researchers to know whether this treatment with 2 drugs is better, the same, or worse than the usual approach (which is sorafenib alone). 

You may be eligible for this research study if you have an advanced Hürthle cell thyroid cancer that does not respond to radioactive iodine. 

Matsangou, MariaMatsangou, Maria
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02143726 STU00202628
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Study Coordinator 312 695 1102
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Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y prom…
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
(a) ≥ 18 years of age;
(b) Hispanic/Latino self-identification;
(c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
(d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
(e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
Miller, GregMiller, Greg
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03344757 STU00203197
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Pizarro, Edgar 312 503 3949
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DRUG CP-MGAH22-04: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

This research study involves an invest…

This research study involves an investigational (test) drug called margetuximab. A test drug means the drug has not been approved by any government office that regulates new medicines. This includes the United States Food and Drug Administration (FDA) and other global government offices. 

Margetuximab targets cancer cells that make too much of a protein called human epidermal growth factor receptor 2, or HER2, which can turn a normal cell into a cancer cell and cause the cancer to grow faster. Cancers are called HER2+ if they are found to express too much HER2 using a test called "IHC" (immunohistochemistry) or another test called "ISH" (in situ hybridization).

Margetuximab is being tested to see if it is safe and may be a potential treatment for metastatic HER2-positive breast cancer. Patients will either receive margetuximab in combination with standard chemotherapy, or margetuximab alone, based on the study doctor’s discretion.

The purpose of this study is to find the answers to these research questions:

  • Can margetuximab be administered safely at a rate faster than 120 minutes?
  • What are the side effects of standard chemotherapy plus margetuximab or margetuximab alone?
  • Do tumors respond (shrink in size) from standard chemotherapy plus margetuximab or margetuximab alone? How long does the response last if they do?

You may be eligible for this research study if you have a confirmed diagnosis of metastatic (has spread to distant organs) or locally-advanced (meaning that your cancer has spread beyond your breast, not to distant parts of your body, and cannot be cured by surgery) HER2-positive breast cancer that has worsened following standard treatments.

Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02492711 STU00202637
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Study Coordinator 312 695 1102
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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegi…

This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.  

The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered (or mutated) genes. Altered genes can cause a tumor to grow. The study drugs, vismodegib and GSK2256098, target these genes. The study drugs could shrink the cancer, or the cancer could stay the same size or grow. They may cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-half compared to its present size. 

Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients.

You may be eligible for this research study if you have a meningioma which has gotten bigger or grew back after treatment. 

Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02523014 STU00202953
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Study Coordinator 312 695 1102
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NU 16I01: Phase I/Ib study of nivolumab in combination with Therasphere (yttrium-90) in patients with advanced hepatocellular carcinoma.
Purpose The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unaccept…
Purpose The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unacceptable side effects, for combination treatment of nivolumab and Y-90. Also, to evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere). Overview Nivolumab is currently FDA approved for other cancers, but has not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Y-90 is currently FDA approved for the treatment of hepatocellular carcinomas, but has not yet been investigated in combination with nivolumab for this disease. This is a phase I study of 2 drugs used in combination: nivolumab and Y-90. We think the combination of these drugs may be more effective against your cancer. Description of Treatment All study participants will get the same study intervention. All study participants will get the study drug Nivolumab. You will receive induction treatment with Y-90, and then approximately four weeks after, you will receive Nivolumab once every 2 weeks (given through the vein over 30 minutes). After you finish your treatment with nivolumab, the study team will continue to watch you for side effects for up to 30 days from your last treatment. If you discontinue from the study for any reason, the study team will continue to check how you are doing every 2 weeks for up to 24 weeks from the start of your treatment.
Some of the eligibility criteria include:

- Patients must have a diagnosis of hepatocellular carcinoma.
- Patients must have advanced disease that is not amenable to transplant or resection.
- Patients may be treatment naÌøve or have received any number of prior therapies

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kalyan, AparnaKalyan, Aparna
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02837029 STU00203003
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Study Coordinator 312 695 1102
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A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the stud…
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. In order for tumors to grow they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune (the study device) is also considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study device, Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient‰Ûªs brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed. Description of Treatment Tumor treatment field therapy with Optune will be initiated at the same time as bevacizumab, with both treatments to start within a one-week period of each other. Bevacizumab will be given at current standard central nervous system (CNS) dosing of 10mg/kg q2 weeks in an outpatient setting. After 4 cycles (1 cycle=28days) of therapy (Cycle 5 day 1) patients may choose to switch to bevacizumab at a dose of 15 mg/kg q3 weeks. For patients who chose to make this switch, they have to do it on Day1 of a new cycle. Tumor treatment fields with Optune will be delivered for at least 18 hours a day at a frequency of 200 KHz and intensity of 1-3V/cm. Treatment will be continued until disease progression or up to 1 year.
"Some of the eligibility criteria include:

- Patients must be age = 18 years. Both males and females and patients from all

ethnic backgrounds are eligible.
- Patients must have a histologic diagnosis of meningioma, WHO grade 2 or 3 (atypical or anaplastic).
- All patients must have developed recurrent disease/progression after receiving all standard treatments.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial."
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02847559 STU00203030
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Study Coordinator 312 695 1102
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NRG GY005-A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)

This Phase III st…

This Phase III study will be done to confirm the effectiveness of the combination of cediranib and olaparib to the standard chemotherapy. Also cediranib alone will be compared with standard chemotherapy for effectiveness. There is no placebo in this study.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for recurrent platinum-resistant or –refractory ovarian cancer. The usual approach is defined as care most people get for recurrent platinum-resistant or –refractory ovarian cancer.

Cediranib is an experimental drug that may help keep cancer cells from growing by affecting their blood supply. Olaparib is a drug that may stop cancer cells from growing abnormally. Olaparib by itself has been approved by the Food and Drug Administration (FDA) for use in women with advanced ovarian cancer with BRCA1 and BRCA2 mutations who had prior chemotherapy. The combination of olaparib and cediranib is investigational. These drugs have been used in other research studies in ovarian cancer, and information from those other research studies suggest that they may help to keep cancer from growing. The addition of cediranib to olaparib could shrink the cancer but it could also cause side effects.

Another purpose of this study is for researchers to learn if a biomarker test is helpful to decide whether or not a patient’s tumor will respond to the study drug(s). Tissue from your surgery will be used for the biomarker test. Extra tubes of blood will be drawn for the biomarker test also. Researchers do not know if using the biomarker test is better, the same, or worse than if you enrolled in this study without using the biomarker test.

You may be eligible for this research study if you have recurrent platinum-resistant or –refractory ovarian, primary peritoneal, or fallopian tube cancer defined as cancer that returned within 6 months of completion of platinum-containing chemotherapy, or continued to get worse during platinum-containing chemotherapy.

Tanner, EdwardTanner, Edward
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02502266 STU00203140
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Study Coordinator 312 695 1102
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NRG-GY006: A Randomized phase II trial of radiation therapy and cisplatin alone or in combination with intravenous triapine in women with newly diagnosed bulky stage IB2, or stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer.

The purpose of this study is to compare …

The purpose of this study is to compare any good or bad effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, compared to using cisplatin chemotherapy and radiation therapy alone. Triapine is an experimental drug being tested in the treatment of cervical cancer to improve the effects of standard radiotherapy with concurrent chemotherapy. The addition of triapine to the usual chemotherapy and radiation therapy could shrink your tumor and increase the length of time till the cancer returns, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

You may be eligible for this research study if you have newly diagnosed cervical or vaginal cancer for which surgical treatment is not possible. 

Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02466971 STU00203105
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Study Coordinator 312 695 1102
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A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
The main goal of …
The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF.
21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02811783 STU00203078
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Jimenez, Javier 312 503 5903
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NU 16B06: Blood Based Prognostic Biomarkers of Breast Cancer Patients – Characterization of clustered CTCs to eliminate Breast Cancer Metastasis

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer …

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

You may be eligible for this research study if you have advanced stage (III/IV)breast cancer.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203283
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Study Coordinator 312 695 1102
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Phase II Multicenter Study of Natalizumab Plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids …

This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids such as prednisone i.e., a corticosteroid), as a new treatment for acute graft versus host disease (GVHD). 

GVHD is the most common serious complication after bone marrow transplant. GVHD occurs when the donor cells (the graft) treat the recipient’s body as “foreign” and attack the cells in the recipient’s body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. GVHD can be severe and potentially fatal to the transplant recipient. The only proven effective treatment for patients with acute GVHD is steroids. Patients who do not respond to steroid treatment are at high risk for death.  

We want to test whether we can improve steroid response and prevent death from GVHD by blocking the donor cells from getting to the intestine and causing damage. 

The study drug, Natalizumab (Tysabri®), is a drug that works by blocking the signals that cause donor cells to travel to the intestine or brain. Natalizumab is FDA-approved in adults to treat Crohn’s disease, a chronic condition where immune cells cause damage to the digestive system (such as the stomach, intestines). It is also used to treat multiple sclerosis where immune cells cause damage to the nervous system in the brain. Its intended use is for patients whose disease has not responded to the standard treatment or if they cannot tolerate the side effects from standard treatments. Natalizumab has never been used for treating GVHD. It is an experimental drug for this study, because we are investigating a new use for the drug as a GVHD treatment.

The goal of this research is to develop safer and more effective treatments for GVHD, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.

You may be eligible for this research study if you have been diagnosed with acute graft-versus-host disease (GVHD) of the GI tract.

Adekola, KehindeAdekola, Kehinde
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02133924 STU00203346
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Study Coordinator 312 695 1102
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An Open Label Phase II Trial of Guadecitabine and Pembrolizumab in Platinum Resistant Recurrent Ovarian Cancer

The purpose of this study is to look at how patients respondto treatment with guadecitabine and pembrolizumab. The researchers will also belooking at the amount of time it takes for cance…

The purpose of this study is to look at how patients respondto treatment with guadecitabine and pembrolizumab. The researchers will also belooking at the amount of time it takes for cancer to get worse when participantstake the study drugs.

All participants will be treated with guadecitabine andpembrolizumab. Guadecitabine is a drug that acts on the cancer cells' DNA. DNAis present inside all cells and guides how proteins are made. Guadecitabineinterferes with the cancer cells' DNA and can increase the production ofcertain proteins, making cancer cells more recognizable by the immune system.Pembrolizumab helps your immune system to kill cancer cells. Thus thecombination of guadecitabine and pembrolizumab may increase the ability of theimmune system to eliminate cancer cells. 

This study will help researchers to find out whether thecombination of guadecitabine and pembrolizumab is effective in treatingovarian, primary peritoneal, or fallopian tube cancer that has not responded totraditional chemotherapy.

You may be eligible for this research study if you have a particular type of ovarian, primary peritoneal, or fallopian tube cancer that has not responded adequately to prior therapy or that we know will not respond to existing therapies.

Matei, DanielaMatei, Daniela
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02901899 STU00203494
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Study Coordinator 312 695 1102
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DRUG AG-221-AML-005: A phase 1B/2 open-label, randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant targeted therapies plus azacitidine: oral AG-120 plus subcutaneous azacitidine and oral AG-221 plus SC azacitidine in subjects with newly diagnosed acute myeloid leukemia harboring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive induction chemotherapy

The purpose of this study, which involves research, is to determine a safe and tolerable dose of the investigational combination of AG-120 plus azacitidine or AG-221 plus azacitidine (Phase 1b) as well as the effectiveness of AG-221 plus azacitidine in treating this disease, when compared to azacitidine alone (Phase 2). AG-120 is not currently approved for the treatment of any type of AML and its use in this study is investigational. Recently AG-221, also known as

enasidenib (IDHIFA®), was approved in the United States (US) for the treatment of adult patients with relapsed or refractory AML with an Isocitrate dehydragenase 2 (IDH2) mutation as detected by an FDA-approved test. The use of enasidenib in this study is investigational. Enasidenib is not currently approved in other countries for the treatment of any type of AML. Azacitidine (Vidaza®) is approved in Canada for the treatment of AML for patients with 20 - 30% bone marrow blast and multi lineage dysplasia, according to WHO classification, who are not candidates to receive hematopoietic stem cell transplantation.

- Adults at least 18 years of age

- Newly diagnosed, primary (i.e., de novo) or secondary (Progression of MDS or myeloproliferative neoplasms [MPN], or therapy-related) AML according to WHO classification with at least 20% leukemic blasts in the bone marrow

- Have an IDH1 or IDH2 gene mutation

- Not candidates to receive intensive IC.

Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02677922 STU00203231
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Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) – A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer…
The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body's immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in this type of cancer. 
You may be eligible if you have non-small cell lung cancer, which has been removed by a surgeon. 
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02595944 STU00203600
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NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

The purpose of the study is to gather information about your cancer and the t…

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

You may be eligible for this research study if you have a diagnosis of cancer and are being treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203944
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OT-15-001: A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Purpose The purpose of this study i…
Purpose The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Overview Elfornithine is an experimental drug. An experimental drug means that the United States Food and Drug Administration (FDA) has not approved it for use. This drug will be used with another drug called Lomustine that is approved by the FDA in the United States for patients with anaplastic astrocytoma. Description of Treatment This study has two study groups. Patients will be randomly placed in one of the 2 groups.
Some of the eligibility criteria include:

- Participants must be 18 years of age or older.

- Patients must have surgical or biopsy proven diagnosis of WHO grade 3 Anaplastic Astrocytoma

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02796261 STU00203957
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NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
Some of the eligibility criteria include:

- participants must have been diagnosed with prostate cancer that is metastatic (has spread outside of the prostate region) and castration-resistant (means the cancer is still growing even when testosterone levels are close to zero)
- participants must be males 18 years of age or above

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03012321 STU00203960
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NU 16C01: A Phase 0 first-in-human study using NU-0129: a spherical nucleic acid (SNA) gold nanoparticle targeting BCL2L12 in recurrent glioblastoma multiforme or gliosarcoma patients
Purpose The purpose of this research study is to evaluate the safety of NU-0129 SNA gold nanoparticle infusion in …
Purpose The purpose of this research study is to evaluate the safety of NU-0129 SNA gold nanoparticle infusion in patients with recurrent glioblastoma multiforme or gliosarcoma Overview This is a first-in-human trial to determine the safety of NU-0129. The study drug is composed of a small gold nanoparticle that has spherical nucleic acid attached to it. This small particle allows NU-0129 to cross the blood brain barrier (a filtering mechanism that carry blood to the brain). Once within the tumor, the nucleic acid component is able to target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of programmed cell death, thus promoting tumor growth. Researchers think that targeting the Bcl2L12 gene with NU-0129 will help stop cancer cells from growing. Description of Treatment All study participants will receive the same study drug, NU-0129, given through vein one time over 20 minutes as an inpatient. Within two days of getting this drug, participants will have a tumor resection surgery, recommended by their doctor. The study team will continue to watch for any side effects for at least 4 weeks with clinic visits and lab tests done each week. The study team will also continue to check how the subjects are doing with a clinic visit at least every 3 months for up to 2 years or until their disease comes back.
Some of the eligibility criteria include:

- Patients should have a diagnosis of recurrent glioblastoma multiforme (GBM) or gliosarcoma (GS) after failing prior therapy.
- Eligible patients must be surgical candidates where surgery is felt to be an appropriate treatment option.
- Patients must be 18 or older.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03020017 STU00203790
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Study Coordinator 312 695 1102
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NU 16H07: Phase II Trial of Pembrolizumab in Combination with ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regim…
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called “ICE” and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently FDA approved for the treatment of melanoma, but has not yet been investigated in Relapsed/Refractory Hodgkin Lymphoma. The ‘ICE’ regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. This is a phase II study of these drugs used in combination. For patients who have a relapse of their Hodgkin’s lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure. Research continues to find for the best regimen to obtain a complete remission in this setting.
Some of the eligibility criteria include:
• Patients must have a histologically confirmed diagnosis of classical Hodgkin lymphoma.
• Patients must have relapsed/refractory disease, with at least one line of prior chemotherapy, but not more than 2 prior lines of treatment, for Hodgkin lymphoma.
• Patients must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03077828 STU00203658
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Study Coordinator 312 695 1102
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A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. T…
EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. These agents often have a side effect of an acne like rash that in some cases can be quite severe. This rash has been shown to be inflammatory in origin but is currently treated with antibiotics if it appears. The main goal of this study is to test if patients treated with steroid cream, (added) which is an anti-inflammatory medication, (added) before a rash develops have a less severe rash than patients who do not use a steroid cream before a rash develops.
Must be 18 years of age or older with a diagnosis of cancer and starting an (changed from 'and') EGFR inhibitor. During the study you must be willing to fill out a daily diary, use sunscreen and cream daily, and fill out 2 questionnaires and have photographs taken every 2 weeks for 4 visits.
Choi, JenniferChoi, Jennifer
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03115567 STU00203631
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Kosche, Cory 312 503 5944
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NU 16B08: Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone Refractory Breast Cancer
Purpose The purpose of this study is to see whether a combination of two different drugs ‰ÛÒ pembrolizumab and capecitabine ‰ÛÒ is safe, and if it might be effective…
Purpose The purpose of this study is to see whether a combination of two different drugs ‰ÛÒ pembrolizumab and capecitabine ‰ÛÒ is safe, and if it might be effective in treating metastatic breast cancer. Overview This is a phase II study in which we will enroll participants to gather more information on how useful and effective the combination of pembrolizumab and capecitibine is in the treatment of triple negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains an antibody. Antibodies are the part of your immune system that finds things that don‰Ûªt belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and blocks a protein, which allows your immune system to target and destroy cancer cells. Pembrolizumab is FDA approved for other types of cancer. It is not approved for breast cancer, meaning that it is an ‰ÛÏexperimental‰Û or ‰ÛÏinvestigational‰Û treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and FDA-approved for breast cancer. It stops the cancer cells from being able to multiply. Description of Treatment All participants enrolled on this study will receive pembrolizumab and capecitabine in 21 day periods called cycles. Pembrolizumab will be given through a vein on Day 1 of each cycle. Capecitabine will be given by mouth twice per day on days 1-14 of each cycle. Participants will continue to receive treatment until their disease gets worse or until they experience an unacceptable side effect. After stopping the study drugs, participants will be assessed every 3 months for up to 1 year with visits and/or phone calls.
Some of the eligibility criteria include:

- Participants must be age 18 years or older and may be male or female.
- Participants must have breast cancer that is either metastatic, can't be removed by surgery, or has spread widely in the area of the breast.
- Participants' breast cancer must be either triple-negative or hormone-positive (if hormone positive, the participant must have progressed on hormonal therapy to be eligible).

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03044730 STU00203215
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Study Coordinator 312 695 1102
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NU 16L04: Parallel proof of concept phase 2 study of nivolumab and metformin combination treatment in advanced non-small cell lung cancer with and without prior treatment with PD-1/PD-L1 inhibitors
The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non…
The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We will also be looking at the safety of the combination. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by the US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is being used to treat cancer. This use is not approved by the FDA; therefore, in this study, it is considered experimental. Experimental means the U.S. FDA has not approved the drug for use in your type of cancer. All study participants will get the same study intervention. All study participants will get the study drugs Nivolumab and Metformin.
You may be eligible for this research study if you have an advanced non-small cell lung cancer, and are age 18 or older. 
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03048500 STU00204354
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Study Coordinator 312 695 1102
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NU 16MH03: Phase I/Ib Study of Nivolumab and Veliparib in Patients with Advanced Solid Tumors and Lymphoma with and without Alterations in Selected DNA Repair Genes

This study is being done to evaluate a drug called veliparib that will be given together with nivolumab for the potential treatment o…

This study is being done to evaluate a drug called veliparib that will be given together with nivolumab for the potential treatment of cancer in subjects with selected advanced solid tumors or lymphoma.

Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body’s immune system to work against tumor cells. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer.

Veliparib inhibits an enzyme in your body known as polyadenosine 5'-diphosphoribose polymerase (PARP). PARP is a naturally occurring protein made by your body that may help cancer cells overcome injury or damage caused by radiation and certain types of anti-cancer drugs, making these treatments less effective (don't work well). Veliparib inhibits (blocks) the activity of PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Veliparib is not yet approved for use in the United States, and is considered experimental. Experimental means the U.S. Food and Drug Administration (FDA) has not approved the drug for use in the type of cancer in this study. 

The purpose of this study is to find the highest and safest dose of the experimental drug veliparib when combined with nivolumab. We will also study how safely this combination of medication can be given in advanced cancer and lymphoma and benefits of receiving this therapy.

You may be eligible for this research study if you have an advanced solid tumor or lymphoma. 

Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03061188 STU00204250
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Study Coordinator 312 695 1102
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Phase II study of nivolumab and ipilimumab for treatment of advanced adenoid cystic carcinoma and non-adenoid cystic carcinoma
Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combinati…
Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combination in participants with this type of cancer. Another purpose of the study is to see which tumor markers (proteins in the blood that the body produces in response to the cancer) lead to better results in participants treated with the study drugs. Overview Nivolumab and ipilimumab are antibodies, which are human proteins that recognize and attach to a part of the tumor and/or body‰Ûªs immune cells. They work in slightly different ways to activate the immune system and help the body‰Ûªs immune system to work against tumor cells. The combination of these drugs is already approved by the FDA to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are investigational because they are not approved by the FDA to be used for the type of cancer being studied. Description of Treatment All study participants will receive the same study drugs, nivolumab/ipilimumab combination, over periods called cycles (1 cycle = 12 weeks / 84 days). Nivolumab will be given through a vein over 30 minutes once every 2 weeks for the first 16 weeks. It will then be given over 60 minutes once every 4 weeks for as long as participants are benefitting. Ipilimumab will be given through a vein over 90 minutes every 6 weeks (twice each cycle). Participants will take part in the study as long as they are benefitting from the study drugs.
Some of the eligibility criteria include:

- Participants must be > 18 years old.
- Participants must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Matsangou, MariaMatsangou, Maria
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03146650 STU00204579
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Study Coordinator 312 695 1102
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(xIRB) DRUG 2215-CL-0201: A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Purpose The purpose of the study is to see if a medicine called ASP2215 given alone or in combination with azacitidine is both effective and safe as a treatment for AML patients with mutations in the FLT3 gene when compared to being treated with azacitidine alone. Overview ASP2215 is a drug that is designed to slow down the growth of leukemic cells by blocking FLT3 protein on those cells. ASP2215 is an experimental drug that is being studied to treat AML. It is being tested in clinical trials and has not been approved by U.S. Food and Drug Administration (FDA) and/or any other regulatory authorities for any indication. Description of Treatment Participants will be randomly (like flipping a coin) assigned to one of three treatment groups: * Group A: ASP2215 given alone; * Group AC: ASP2215 given in combination with azacitidine chemotherapy; * Group C: azacitidine chemotherapy given alone. During the treatment period, the study is divided into periods of time called cycles. Each cycle lasts 28 days. Participants will come into the clinic each cycle for visits to get more study drug and to evaluate AML and other related health assessments.
Some of the eligibility criteria include:

- Participant is at least 18 years old.
- Subject has a diagnosis of previously-untreated AML.
- Subject is positive for FLT3 mutation (ITD or TKD [D835/I836] mutation) in bone marrow or whole blood.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Dinner, ShiraDinner, Shira
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02752035 STU00203834
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Study Coordinator 312 695 1102
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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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312 695 8146
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NU UP16M02 The BAMM Trial: BRAF, Autophagy and MEK inhibition in Metastatic Melanoma: A Phase I/II Open Label Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients with Advanced BRAF Mutant Melanoma

This is a research study involving the use of the drugs hydroxychloroquine (Plaquenil)…

This is a research study involving the use of the drugs hydroxychloroquine (Plaquenil), dabrafenib (Tafinlar®Novartis), and trametinib (Mekinist®Novartis). Hydroxychloroquine is FDA approved for select non-cancer disorders at lower doses, but is not FDA approved for the treatment of cancer, and therefore is considered “investigational” as used in this study. Dabrafenib and trametinib are FDA-approved for the treatment of mutant melanoma. All three drugs have each been given to more than 10,000 patients each worldwide as separate agents, but, all three have not yet been approved when combined together. In this trial hydroxychloroquine is being studied as a potential anticancer medicine. The reasons for combining these three drugs is that dabrafenib and trametinib together effectively block a protein called BRAF, which drives the growth of melanoma. In response, the melanoma cells activate a stress response called autophagy. Autophagy provides resistance to dabrafenib and trametinib treatment over time making it less effective. We are using hydroxychloroquine, which may impair autophagy and therefore block this key resistance mechanism, to increase the number of dead cancer cells when combined with dabrafenib and trametinib.

The purpose of this study is to:

  • Determine the maximum tolerated dose of hydroxychloroquine which can be safely combined with dabrafenib and trametinib
  • Determine how effective this three drug combination is in shrinking tumors
  • Perform laboratory based tests to assist in understanding how these drugs work in patients with advanced melanoma

You may be eligible for this research study if you have advanced metastatic melanoma, a type of malignant skin cancer.

Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02257424 STU00204561
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Study Coordinator 1 312 695 1102
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A PHASE I STUDY OF NEURAL STEM CELL BASED VIROTHERAPY IN COMBINATION WITH STANDARD RADIATION AND CHEMOTHERAPY FOR MALIGNANT GLIOMA
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Bas…
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diganosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.
Inclusion Criteria:
•Patients must have presumed malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of stereotactic biopsy or resection prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
•Tumor must be accessible for injection and must not be located in the brainstem, or contained within the ventricular system.
•Planning to undergo standard radiation/chemotherapy
•18 years of age or older.
•Performance status must be KPS ≥ 70
•SGOT (AST) < 3x upper limit of normal
•Serum creatinine < 2mg/dl
•Platelets > 100,000/mm3 and WBC > 3000/mm3

Exclusion Criteria:
•Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection.
•Immunosuppressive drugs (with exception of corticosteroid).
•Known HIV+ patients.
•Acute infections (viral, bacterial or fungal infections requiring therapy).
•Pregnant or breast-feeding patients.
•Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
•Prior radiation therapy to the brain or prior treatment for brain tumor Other serious co-morbid illness or compromised organ function
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03072134 STU00203933
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Amidei, Christina 312 695 9124
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NCI 2015-06-04 Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02993159 STU00204804
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Xu, Yanfei 1 312 472 0595
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Melanoma and Skin Cancer Tissue Repository

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine…

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion. 

Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204151
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Study Coordinator 1 312 695 1102
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BTCRC GYN15-013: Phase II Study of Pembrolizumab in Combination with Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and ca…
The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and carboplatin chemotherapy.
Participants will be adults with cancer in the lining of the uterus (endometrium) that has spread to other parts of the body or has returned after initial treatment.
Matei, DanielaMatei, Daniela
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02549209 STU00204968
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Study Coordinator 312 695 1102
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NCI 2015-06-03 Statin Therapy to Reduce Disease Progression from Liver Cirrhosis to Cancer
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg d…
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg daily or placebo daily, a pill that looks like simvastatin 40 mg but contains no medication. Simvastatin is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk for heart attack, stroke, and chest pain in patients who have heart disease or risk factors for heart disease such as smoking, high blood pressure, low high-density lipoprotein (HDL), or family history of early heart disease. It is also approved to lower the risk for heart attack or stroke in patients with type 2 diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure. However, simvastatin is not approved by the FDA to decrease the risk of liver cancer. Simvastatin is considered “investigational” (a study drug) in this study. Studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. We believe that this anti-inflammatory effect of simvastatin may help patients with liver cirrhosis.
Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Leukocytes >= 2,500/microliter
Absolute neutrophil count >= 1,500/microliter
Platelets >= 50,000/microliter
Hemoglobin >= 10 g/dL
Total bilirubin =< 3 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN
Creatinine =< 1.5 x institutional ULN
Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
Women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Ability to understand and the willingness to sign a written informed consent document and medical release
Willing and able to comply with trial protocol and follow-up
Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 7 months
Kulik, Laura MKulik, Laura M
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02968810 STU00204992
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Sipich, Kimberly A 312 694 1293
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(xIRB) S1418/BR006 A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy.
The purpose of this study…
The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach.
 
Gradishar, William JGradishar, William J
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02954874 STU00205340
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1 312 695 1102
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Alliance A221405 Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer

The purpose of this study is to determine whether having a child after temporarily stopping endocrine treatment is feasible and safe in patients with a hormone receptor-positive …

The purpose of this study is to determine whether having a child after temporarily stopping endocrine treatment is feasible and safe in patients with a hormone receptor-positive early breast cancer. Specifically, the study will investigate whether a temporary interruption of endocrine therapy, with the goal of permitting pregnancy and then resuming endocrine therapy to complete a standard course, is associated with a higher risk of breast cancer recurrence. 

The best available evidence suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a recurrence from her breast cancer. The most recent data also suggest that this is true in women with a hormone receptorpositive breast cancer. While delivery complications have been reported, available information does not suggest an increased risk for delivery complications or for newborns. This new study aims to clarify these results and to help determine how long a woman should wait before trying to become pregnant after breast cancer diagnosis and treatment.

Some of the eligibility criteria include:

• Study participants must be at least 18 years old.

• Study participants must have been diagnosed with and treated for hormone receptor-positive early breast cancer.

• Study participants are currently taking endocrine therapy.

• Study participants must have expressed interest in getting pregnant.

Participants will temporarily stop current endocrine therapy and attempt to become pregnant. They must have taken at least 18, and not more than 30, months of endocrine treatment before stopping; and they must wait three to five months after stopping endocrine treatment before attempting to become pregnant. Whether they become pregnant or not, they should resume endocrine therapy within 2 years after the endocrine therapy interruption and complete five to ten years of treatment, according to individual risk and preference, as planned with their treating oncologist. 

Flaum, LisaFlaum, Lisa
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02308085 STU00205165
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Study Coordinator 1 312 695 1102
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NU 16B14: I-CURE-1: A Phase II, single arm study of Pembroluzimab combined with carboplatin in patients with circulating tumor cells (CTCs) positive Her-2 negative metastatic breast cancer (MBC)

Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence,&n…

Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence, those tumors are more resistant to chemotherapy and may be associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells.

This drug has been found effective in other type of cancer and already approved by FDA for those indications, but the efficacy in breast cancer is still unknown. Pembrolizumab will be combined with chemotherapy, a drug called carboplatin, to increase the cancer cell killing. There is no control or placebo treatment in this study. Use of Pembrolizumab in this study is considered investigational, meaning that the drug is not approved for the indication under investigation.

You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03213041 STU00205013
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Study Coordinator 312 695 1102
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(xIRB NCI CIRB) SWOG 1609 DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Purpose The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. Overview…
Purpose The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. Overview The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-quarter compared to its present size. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin. Description of Treatment All study participants will get the same study drugs: ipilimumab and nivolumab. Participants will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and they will receive nivolumab through a vein every 2 weeks. Participants will continue to receive study drugs until their disease gets worse or they experience bad side effects from the study drugs or their study doctor decides that they are not benefiting from the study drugs.
Some of the eligibility criteria include:

- Participants must be at least 18 years of age or older.

No other prior malignancy is allowed except for the following:

1. Adequately managed Stage I or II cancer from which the participant is currently in complete remission

2. Any other cancer from which the participant has been disease free for one year.

3. Adequately managed Stage I or II follicular thyroid or prostate cancer is also eligible, in which the participant is not required to be in complete remission

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02834013 STU00205572
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Study Coordinator 1 312 695 1102
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NU JH17U01: Overcoming drug resistance in metastatic castration-resistant prostate cancer with novel combination of TGF-β receptor inhibitor LY2157299 and enzalutamide: a randomized multi-site phase II study

This research is being done to test the effectiveness (anti-tumor activity) and safety of…

This research is being done to test the effectiveness (anti-tumor activity) and safety of combining enzalutamide with LY2157299 for the treatment of men with advanced castrate-resistant prostate cancer. 

Enzalutamide blocks testosterone production in the body to slow or stop the growth of prostate cancer cells. Enzalutamide (Xtandi®) is approved by the FDA for the treatment of patients with advanced castrate resistant prostate cancer who have received chemotherapy. 

LY2157299 is an investigational drug that inhibits a growth factor that is believed to play a role in the spread of the cancer. The use of LY2157299 in this research study is investigational. The word “investigational” means that LY2157299 is not approved for marketing by the Food and Drug Administration (FDA).

You may be eligible for this research study if you are a man with advanced castrate resistant prostate cancer.

Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000417 STU00205208
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Study Coordinator 312 695 1102
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MY PATHWAY: AN OPEN-LABEL PHASE IIA STUDY EVALUATING TRASTUZUMAB/PERTUZUMAB, ERLOTINIB, VEMURAFENIB/COBIMETINIB, VISMODEGIB, ALECTINIB, AND ATEZOLIZUMAB IN PATIENTS WHO HAVE ADVANCED SOLID TUMORS WITH MUTATIONS OR GENE EXPRESSION ABNORMALITIES PREDICTIVE OF RESPONSE TO ONE OF THESE AGENTS
Trastuzumab…
Trastuzumab/Pertuzumab combination, Erlotinib, Vemurafenib/Cobimetinib combination, Vismodegib, Alectinib and Atezolizumab are agents that target specific proteins that cause or contribute to the growth and spread of cancers. These targeted therapy agents have been tested and approved by the US FDA to treat some types of cancer but not others. The purpose of this research study is to evaluate whether these targeted drugs is safe and effective for the treatment of other types of cancers. Many cancers contain molecular abnormalities that cause or contribute to their ability to grow and spread. These molecular and genetic changes can be detected in the laboratory tests. By blocking the effects of these abnormalities, the growth of cancer may be stopped or slowed down. Many new cancer drugs work in this way. Because they block the effects of specific molecular abnormalities within the cancer, they are known as “targeted” agents. Patients are now able to have molecular tests done on their tumor tissue (“molecular profiling”), in order to identify potential molecular abnormalities that may be treated with targeted drugs. Some of these targeted drugs have been approved by the US FDA to treat certain types of cancer but not others. The purpose of this study is to evaluate if these targeted drugs is safe and effective for the treatment of other types of cancers.
Some of the eligibility criteria include:1) Molecular testing results from a certified lab showing an abnormality that can be targeted with any of the above agents; 2) Able to understand the nature of this trial and provide written informed consent; 3) Participants must be 18 or older.
Villaflor, VictoriaVillaflor, Victoria
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02091141 STU00205235
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Study Coordinator 312 695 1102
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DRUG CA209-816: Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the …
The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the drug works) of nivolumab in combination with ipilimumab and nivolumab in combination with plantinum doublet chemotherapy in subjects with non-small cell lung cancer.
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02998528 STU00205030
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Study Coordinator 312 695 1102
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NU UW16B13: A Phase II Study of Neratinib Alone and in Combination with Fulvestrant in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
Certain types of breast cancer test positive for overexpression HER2 (a protein involved in normal cell growth) and some test negative. Some patients may …
Certain types of breast cancer test positive for overexpression HER2 (a protein involved in normal cell growth) and some test negative. Some patients may have HER2-negative breast cancer with mutations in HER2. Neratinib is an investigational drug - meaning that it has not been approved by the U.S. Food and Drug Administration [FDA] - shown to be effective for treating HER2-positive breast cancer in clinical trials. An additional routine treatment involves a drug called Fulvestrant, which blocks the effects of estrogen in breast tissue. In this study, the uses of neratinib alone or in combination with Fulvestrant, will be studied, to see how the cancer responds to these treatments in each population.
Diagnosis with metastatic breast cancer at the time of screening
Diagnosis of metastatic breast cancer that is HER2-negative, but found to have a mutation in HER2 at the time of enrollment
Age of at least 18 years
Completion of radiation therapy and be at least 1 week from the last administration before starting study treatment
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01670877 STU00205349
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Study Coordinator 312 695 1102
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BTCRC-GI15-015: A Phase II Study of FOLFOX combined with Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen…

This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen called FOLFOX have any effect on stomach cancer or cancer where the esophagus and the stomach meet. The study drugs could shrink your cancer but it could also cause side effects.

Nab-paclitaxel is a new formulation of a chemotherapy called paclitaxel. Regular paclitaxel is made with stabilizers that cause allergic reactions in many patients. Nab-paclitaxel does not use these stabilizers which means more of the drug can be given with fewer allergic reactions. Nab-paclitaxel (Abraxane®) is approved by the U.S. Food and Drug Administration (FDA) to treat breast, lung, and pancreas cancers. 

FOLFOX stands for a combination of three drugs: oxaliplatin, leucovorin, and 5-fluorouracil. Oxaliplatin is a chemotherapy approved by the FDA to treat colon and rectal cancer. Leucovorin is not a chemotherapy. It is form of folic acid and it is given with 5-fluorouracil to help increase the anti-cancer effects of 5-fluorouracil. It is approved by the FDA to be given with fluorouracil in patients with advanced colorectal cancer. 5-fluorouracil is approved by the FDA to treat cancers of the breast, stomach, colon, rectum, and pancreas.

Combining nab-paclitaxel with FOLFOX should be considered investigational. Investigational means that the FDA has not approved this combination of drugs for stomach cancer or cancer where the esophagus and the stomach meet.

 

Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03283761 STU00205558
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Study Coordinator 1 312 695 1102
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DRUG PCYC-1145-LT: Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials

Pharmacyclics Switzerland GmbH is conducting this protocol to provide long term access to ibrutinib for subjects who have been enrolled in ibrutinib studie…

Pharmacyclics Switzerland GmbH is conducting this protocol to provide long term access to ibrutinib for subjects who have been enrolled in ibrutinib studies that are being closed and are actively receiving treatment with ibrutinib and deriving benefit. 

Ibrutinib is a type of drug called a “kinase inhibitor”. Ibrutinib (IMBRUVICA®) has been approved in many regions, including the US and EU for indications covering the treatment of patients with: 1) mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, 2) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) including CLL/SLL patients with a 17p deletion and 3) Waldenstrom’s macroglobulinemia (WM). 

You may be eligible for this research study if you are, 1) participating in an ibrutinib clinical trial which will end soon, 2) deriving clinical benefit from treatment with ibrutinib in the opinion of your treating physician and 3) do not have adequate access to commercial ibrutinib within your region.

Ma, ShuoMa, Shuo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03229200 STU00205716
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Study Coordinator 312 695 1102
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Clinical Database of Nephrectomy at Northwestern University
The goal of this study is to determine the current clinical outcomes of our nephrectomy patients at Northwestern (such as complications and survival). We hope to keep track of patients for the first 5-years following radical or partial nep…
The goal of this study is to determine the current clinical outcomes of our nephrectomy patients at Northwestern (such as complications and survival). We hope to keep track of patients for the first 5-years following radical or partial nephrectomy in order to better understand the long-term behavior of the disease.
Patients ages 18-89 with a diagnosis of kidney cancer.
Nadler, Robert BNadler, Robert B
STU00205973
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312 695 6124
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DRUG CA209-914: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to test the effectiveness (how well…

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return. 

Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. 

OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung, in multiple countries including the United States, the European Union, and Japan. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The combination of nivolumab (Opdivo™) and ipilimumab (Yervoy™) is also approved by the US FDA for the treatment of advanced kidney cancer that has spread to other parts of the body and by the US FDA and the EMA for the treatment of metastatic melanoma.

You may be eligible for this research study if you have kidney cancer and have had your tumors completely removed but are at risk of having your cancer return.

Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03138512 STU00205491
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Study Coordinator 312 695 1102
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(xIRB NCI-CIRB) SWOG 1512: A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unsectable Desmoplastic Melanoma (DM)
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembr…
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembrolizumab) could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will cause the cancer to at least temporarily disappear in more than twenty percent of patients with melanoma that is not surgically removable. In patients with melanoma that is surgically removable, researchers also hope to learn if the study drug will cause the surgery to be more effective and avoid repeated surgery.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02775851 STU00205551
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Study Coordinator 312 695 1102
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A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
This research study is investigating a drug (that is called IMCgp100) in patients with a…
This research study is investigating a drug (that is called IMCgp100) in patients with advanced uveal melanoma. Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the immune system, known as immunotherapies. In this research study, IMCgp100 will be compared to three representative standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug targeting a protein called CTLA-4), or pembrolizumab (an immunotherapy drug targeting a protein called PD-1). This research study is being done to assess the efficacy and safety of the IMCgp100 in patients with uveal melanoma in comparison to these standard treatments.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000418 STU00205550
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Study Coordinator 312 695 1102
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Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the inter…
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous) through a vein. About 12 people are expected to participate in this research study here at Northwestern University out of 160 people in the entire study nationally.
Some of the eligibility criteria include:
• Participants must be 18 or older.
• Patient must have the ability to understand and sign an approved informed consent form (ICF).
• Patient must have a confirmed diagnosis of advanced Renal Cell Carcinoma (RCC).
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Sosman, JeffreySosman, Jeffrey
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03117309 STU00205969
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Study Coordinator 312 695 1102
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Clinical Database of Prostate Cancer at Northwestern University
The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
Men ages 18-89 years daignosed with prostate cancer.
Schaeffer, EdwardSchaeffer, Edward
STU00206270
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Khawaja, Faizan 312 694 2417
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ALLIANCE A021501 PREOPERATIVE EXTENDED CHEMOTHERAPY VS. CHEMOTHERAPY PLUS HYPOFRACTIONATED RADIATION THERAPY FOR BORDERLINE RESECTABLE ADENOCARCINOMA OF THE HEAD OF THE PANCREAS
The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiati…
The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.
You may be eligible for this study if you have pancreatic cancer that cannot be removed by surgery at this time.
Kalyan, AparnaKalyan, Aparna
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02839343 STU00205727
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Study Coordinator 1 312 695 1102
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NU 16B19: Automated system for creating custom three-dimensional radiofrequency ablation lesion geometries in post-lumpectomy margin ablation breast cancer treatment

When a lumpectomy or excisional biopsy is performed to remove cancer, the surgeon attempts to create a cancer-free zone or “margin…

When a lumpectomy or excisional biopsy is performed to remove cancer, the surgeon attempts to create a cancer-free zone or “margin” around the removed area. In order to create this margin or safety zone, heat can be used to kill pre-cancerous or cancerous cells in the zone around where the cancer once existed. This process is called “ablation”. We wish to test an ablation method that can be added to future breast cancer surgeries. To do this, we need donated breast tissue from people who have mastectomies performed.

The heat source being investigated in this study is radiofrequency ablation (RFA). In this study a new RFA device design will be tested. These devices have a spacing applicator to form fit to the tissue around a lumpectomy for optimal treatment. These devices are in the development phase and have not yet been approved by the Food and Drug Administration (FDA), however, because the procedure is done on tissue that has been removed from the body, there is not a physical risk from the use of the device. This study will allow us to analyze the effectiveness of the devices and improve their use and design before they are used to treat breast cancer patients who receive lumpectomy.

You may be eligible for this research study if you are scheduled to undergo a mastectomy on one or both of your breasts. 

Bethke, KevinBethke, Kevin
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206005
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Study Coordinator 1 312 695 1102
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DRUG 2401BT-002P: A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) with Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma

In this study, there are two study drugs: DNX-2401 and pembrolizumab. The study drug (DNX-2401), when injected…

In this study, there are two study drugs: DNX-2401 and pembrolizumab. The study drug (DNX-2401), when injected into a brain tumor, may shrink or slow the growth of the tumor. The addition of the study drug intravenous (IV) pembrolizumab may also shrink or slow the growth of the tumor and could allow DNX-2401 to work better inside the tumor. They will both act against cancer in ways that involve the body's immune defense system. 

The purpose of this research study is to:

  • find out how much DNX-2401 is best to give once into the brain tumor when followed by intravenous (IV) pembrolizumab infusions;
  • learn whether or not the study drug (DNX-2401) followed by IV pembrolizumab will shrink brain tumors compared to their present size as assessed by regular MRI (magnetic resonance imaging);
  • find out whether DNX-2401 given into the brain tumor followed by IV pembrolizumab infusions every 3 weeks will change the way the virus DNX-2401 behaves in the brain tumor cells as it is attacking the tumor;
  • find out what effects DNX-2401 and pembrolizumab, used together, have on general health over time by testing urine and blood.

This is an investigational study. The Food and Drug Administration (FDA) has allowed DNX2401 to be used for research purposes only, so it is considered experimental. Pembrolizumab (KEYTRUDA®) is approved for other types of cancer but it has not been approved for use in people with brain cancer, and is considered experimental when used as it is used in this study. Using them together in the same study is a new experimental approach. It is not possible to predict whether the anticancer effects will be stronger when these two experimental study drugs are used together.

You may be eligible for this research study if youhave a malignant brain tumor called glioblastoma or gliosarcoma that is recurrent, or has comeback following initial surgery and treatment. 

Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02798406 STU00204494
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Study Coordinator 312 695 1102
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NU 17U19: Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer

This study will help researchers understand what men go through when being treated for their cancer. Specifically, the purpose of this study is to:

1. Assess the way men think during treatme…

This study will help researchers understand what men go through when being treated for their cancer. Specifically, the purpose of this study is to:

1. Assess the way men think during treatment for prostate cancer during specific treatments for prostate cancer.

2. Follow the thinking process during prostate cancer treatment over time.

3. Identify genetic variations that might make men more or less sensitive to thinking changes during treatment for prostate cancer. Genes are the instruction manual for your body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person’s risk for certain diseases and how they will respond to treatment. 

You may be eligible for this research study if you have prostate cancer and are interested in helping researchers understand what men go through when being treated for their cancer. 
Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03016741 STU00206082
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Study Coordinator 1 312 695 1102
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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, EdwardSchaeffer, Edward
NCT03392181 STU00205957
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Khawaja, Faizan 312 694 2417
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BMT CTN-1506: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML

The main purpose of this study is to learn if it is safe and effective (works…

The main purpose of this study is to learn if it is safe and effective (works well) to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. We want to know if this drug works better than a placebo (pill that contains no drug, like a sugar pill) to stop the AML from coming back after allogeneic transplant. We also want to know if there are side effects when gilteritinib is given to people with FLT3/ITD AML.

Gilteritinib is an experimental drug that is being studied to treat FLT3/ITD AML. It is being tested in clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities to treat any disease.

You may be able to take part in this research study if you have acute myeloid leukemia (AML) with a genetic mutation (change in your DNA) called FLT3/ITD, and you are planning to have an allogeneic stem cell transplant.
Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02997202 STU00205841
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Study Coordinator 312 695 1102
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Shared Decision Making in Advanced Prostate Cancer
This study will help researchers understand what men go through when makingdecisions for treating their cancer. Specifically, the purpose of the study is to: 

1. Assess the treatment decision making process of men with advanced prostate cancer…

This study will help researchers understand what men go through when makingdecisions for treating their cancer. Specifically, the purpose of the study is to: 

1. Assess the treatment decision making process of men with advanced prostate cancer. 

2. Determine whether the amount of patient participation in decisions affects patientoutcomes, such as quality of life and satisfaction with the decision. 

3. Help researchers learn how to make treatment decision-making easier and lessconfusing for men with prostate cancer.

You may be eligible for this research study if you have prostate cancer and are interested in helping researchers understand what men go through when making decisions for treating their cancer.

Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206080
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Study Coordinator 1 312 695 1102
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AN OPEN-LABEL, PHASE 2 STUDY OF NERATINIB IN PATIENTS WITH SOLID TUMORS WITH SOMATIC HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR, HER2, HER3) MUTATIONS OR EGFR GENE AMPLIFICATION

Neratinib is an experimental drug in this study and is being studied as a potential new treatment for patients with ca…

Neratinib is an experimental drug in this study and is being studied as a potential new treatment for patients with cancers which carry specific mutations in genes of the ERBB family of growth factor receptors (EGFR, ERBB2, ERBB3, or ERBB4 also referred to as HER1, HER2, HER3, or HER4).  Growth factor receptors are proteins present on the cell surface that receive signals on when to divide and grow. These mutations are believed to have a role in abnormal growth of cells that can lead to oncogenesis, which is the transformation of a normal cell to a cancer cell.  An experimental or investigational drug means it has not been approved by the US Food and Drug Administration (USFDA) for these indications.

 

This study will enroll patients who have any solid tumors that have mutations in EGFR mutations, ERBB2 or ERBB4 including but not limited to bladder/urinary tract cancer, biliary tract, gastroesophageal (includes esophageal, gastro-esophageal and gastric cancers), breast, solid tumors not otherwise specified (ERBB2 and ERRB4), cervical, lung, colorectal and ovarian cancer. The reason why neratinib is being tested in patients with these types of cancers is because it is believed that when an ERBB2, ERBB 4 or EGFR mutation occurs in a tumor, it will help the tumor grow and neratinib may decrease the effect of these mutations on cancer growth.

 

The purpose of this study is to find out what effects, good and/or bad, neratinib, either by itself (monotherapy) or in combination with other drugs has in solid tumors harboring somatic EGFR mutations, ERBB2 or ERBB4 mutations.

Some of the eligibility criteria include:

  • Participants must be 18 or older.
  • Patient must have the ability to understand and sign an approved informed consent form (ICF).
  • Patient must have a confirmed diagnosis of cancers with mutations in ERBB family
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT01953926 STU00206494
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Study Coordinator 312 695 1102
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(xIRB) NCI 9767: An Open Label, Multicenter, Single arm Phase II study to evaluate the Activity and Tolerability of the novel mTOR Inhibitor, MLN0128 (TAK-228), in patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the urothelial tract whose tumors harbor a TSC1 and/or TSC2 mutation.
The purpose of this study is to test any good and bad effects of the study drug called MLN0128 (TAK-228). This study is being done to see if MLN0128 (TAK-228) is effective in treating this type of cancer.
• Participants must be 18 years or older
• Participants must have a urinary tract cancer that has spread because the cancer has a mutation in TSC1 and/or TSC2 genes.
• Participants must have already been treated with chemotherapy, but their disease is still growing
Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03047213 STU00206603
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Study Coordinator 312 695 1102
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Phase Ib, open label, combination study of nintedanib with 5- azacitidine in acute myeloid leukemia characterized by HOX gene overexpression, that are not candidates of intensive chemotherapy
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with aza…
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant’s response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant’s leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.

You may be eligible for this research study if you have a specific type of disease of the blood cells and bone marrow called acute myeloid leukemia, and you have declined standard intensive chemotherapy or it has been medically determined not to be in your best interest. It may also be that your disease has returned after initial treatment and disappearance of evidence of cancer, or you may not have responded to treatment during initial therapy. You may be eligible to receive treatment on this trial if your leukemia cells have overexpression (abnormal amount) of HOX genes. 

Altman, Jessica KAltman, Jessica K
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03513484 STU00206525
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Study Coordinator 1 312 695 1102
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A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses…

This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses) drug called valganciclovir. “Investigational” means the drug being tested (VRx-3996) has not been approved by the United States Food and Drug Administration (FDA). The antiviral drug, valganciclovir, has been FDA-approved to prevent and treat certain types of viral infections. Some people may already have received or are currently taking the antiviral drug, valganciclovir, for their disease.

The primary purpose of this study is to determine how safe is it to take the investigational drug (VRx-3996) along with valgaciclovir and find the maximal dose that can be taken safely. The study will also determine if the cancer responds to treatment with the drug combination. The study will also evaluate how much of the study drug is present in your blood at different time points.

You may be eligible for this research study if you have a cancer, called lymphoma, that tested positive for Epstein-Barr Virus (EBV). 

Karmali, ReemKarmali, Reem
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03397706 STU00206699
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Study Coordinator 312 695 1102
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DRUG KCP-330-020: A Phase 2-3, Multicenter, Randomized, Double-Blind Study of Selinexor (KPT-330) Versus Placebo in Patients with Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

The purpose of this research study is to see if selinexor has any effects against advanced unresectable dediff…

The purpose of this research study is to see if selinexor has any effects against advanced unresectable dedifferentiated liposarcoma (DDLS). 

Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. In cancer cells one or more of these control mechanisms has failed, or been tempered with, leading to uncontrollable growth. One specific way cancer cells continue to grow is by getting rid of certain proteins called “tumor suppressor proteins” that would normally cause cancer cells to die. Selinexor works by trapping “tumor suppressing proteins” within the nucleus of the cells and thus causing the cancer cells to die or stop growing. 

Selinexor has previously been tested in humans to define a safe dose to be administered. It is not known at this time if selinexor will treat your cancer. Selinexor (also known as KPT-330) is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). This study will examine the effects of selinexor on your cancer and on your body including any side-effects that you may experience.

You may be eligible for this research study if you have been diagnosed with an advanced unresectable dedifferentiated liposarcoma (DDLS), your previous treatment(s) have not been successful and your cancer is progressing.

Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02606461 STU00206790
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Study Coordinator 312 695 1102
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Next-Generation sequencing of cell-free circulating tumor DNA in locally invasive bladder cancer
bloodstream. These pieces are called cell-free circulating tumor DNA (cfDNA). Recent studies in lung and breast cancers have shown that cfDNA can be screened for certain mutations to detect and follow t…
bloodstream. These pieces are called cell-free circulating tumor DNA (cfDNA). Recent studies in lung and breast cancers have shown that cfDNA can be screened for certain mutations to detect and follow the growth of a patient’s tumor. This study aims to apply this technique to bladder cancer and to identify specific mutations unique to varying stages of bladder cancer. This technology has been applied to other cancers but has not yet been studied in bladder cancer. We plan to determine whether this technology is able to identify genetic mutations linked to bladder cancer.
Patients age 18-89 years old with early invasive (T1) and muscle invasive (T2+) bladder cancer .
Meeks, Joshua JMeeks, Joshua J
STU00206645
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312 695 8146
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A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®18087 in Subjects with Advanced Neuroendocrine and Gastrointestinal Stromal Tumors

The primary purposes of this research study is to determine the safety and tolerability of the investigational drug, XmAb18087, and moni…

The primary purposes of this research study is to determine the safety and tolerability of the investigational drug, XmAb18087, and monitor for side effects from the drug to find the best dose for treating neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST). 

XmAb18087 is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States. 

This study will also measure the amount of XmAb18087 in the blood at various times, whether or not the body makes antibodies against XmAb18087, and the effect XmAb18087 may have on cancer. An antibody is a protein made by the body’s immune (defense) system to fight infection and other types of harmful cells or substances in the body by attaching to them. Antibodies against XmAb18087 could reduce the amount of the study drug in the blood and the effects of the study drug on your cancer. The blood will be checked regularly during this study to see if the immune system has made antibodies against XmAb18087. This is called “anti-drug antibody” (ADA) testing.

You may be eligible for this research study if you have either neuroendocrine (endocrine (hormonal) and nervous systems) tumors (NET) that originated in your pancreas, stomach or intestines, lungs or in an unknown location, or you have gastrointestinal stromal (structural parts of the stomach and intestines) tumors (GIST) and your cancer has either relapsed or not responded to standard cancer therapies.

Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03411915 STU00206730
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Study Coordinator 312 695 1102
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A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA (Protocol #RD.03.SPR.104003)
This study is being done to …
This study is being done to assess the efficacy and safety of two concentrations of Resuiqimod gel in the treatment of CTCL (stage IA, IB, IIA). In addition, this study will test the systemic effect of Resiquimod gel on lesions distant from the treatment areas.
Must be 18 years or older with a clinical diagnosis of Cutaneous T Cell Lymphoma with at least three distinct lesions, including one distant lesion.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03292406 STU00206325
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Jimenez, Javier 312 503 5903
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PCCTC-c16-170: IRONMAN: International Registry for Men with Advanced Prostate Cancer
This is a registry study. The purpose of the study is to learn more about prostate cancer and

  • to describe the use of different therapies for advanced prostate cancer internationally;
  • to desc…
This is a registry study. The purpose of the study is to learn more about prostate cancer and

  • to describe the use of different therapies for advanced prostate cancer internationally;
  • to describe specific treatment patterns and whether they are associated with differences in outcomes such as hospitalizations;
  • to identify associations between treatment sequences or combinations and overall survival;
  • to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment;
  • to identify clinical and molecular disease subtypes that may predict for a reduction in cancer from individual treatments, combinations, or sequences.

You may be eligible for this IRONMAN Registry research study if you have been diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) or nonmetastatic (M0) / metastatic (M1) castration-resistant prostate cancer (CRPC). If you have prostate cancer that has spread to another part of your body and you have not received hormonal therapy, then you have mHSPC. If you have already been treated with androgen deprivation therapy and your disease is now growing despite a low testosterone level, you have CRPC.

Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206648
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Study Coordinator 312 695 1102
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A Phase 1/2a, Multicenter, Open Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer

LYC-55716 is an investigational drug that is beingdeveloped by Lycera Corporation (the “Sponsor” of the research Study) for usein locally advanced or metastatic tumors. “Inve…

LYC-55716 is an investigational drug that is beingdeveloped by Lycera Corporation (the “Sponsor” of the research Study) for usein locally advanced or metastatic tumors. “Investigational” means that LYC-55716has not been approved by the United States Food and Drug Administration (FDA)for use as a prescription or over-the-counter medication to treat a certaincondition.  At Northwestern University, about8 people are expected to be enrolled in the phase 2 portion of this researchstudy out of 120 people in the entire study.

 

The primary purposeof this Study is to determine how safe the study drug is, identify the dose ofthe drug that can be taken safely (phase1 part) and what effect the study drug hason your disease (phase 2 part). If you are found to qualify and decide toenroll in this study, you will enroll in the phase 2 part and undergo studytreatment for approximately six months. You will take three LYC-55716 tabletsorally, twice daily, approximately 12 hours apart for about 24 weeks. If youshow signs of clinical benefit, and tolerate LYC-55716 adequately, you mayreceive additional cycles of treatment beyond 24 weeks until your disease getsworse or you experience intolerable side effects. You will also be followed forabout 1 year after your last dose of the study drug to see how you are doing.

Some of the eligibility criteria include:

  • Participants must be 18 or older.
  • Patient must have the ability to understand and sign an approved informed consent form (ICF).
  • Patient must locally advanced or metastatic cancer.
Note: This is only apartial list of eligibility criteria. Please contact the Robert H. Lurie ComprehensiveCancer Center of Northwestern University for complete screening information ifyou are interested in this clinical trial.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT02929862 STU00206768
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Study Coordinator 312 695 1102
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DRUG NLG0705: Long Term Follow-Up Study for Subjects Previously Treated with Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

The purpose of this clinical study is to determine if there are any long term safety risks for research subjects who have received the investigational algenpantucel-L im…

The purpose of this clinical study is to determine if there are any long term safety risks for research subjects who have received the investigational algenpantucel-L immunotherapy (DRUG NLG-0205 or DRUG NLG-0405) in a clinical trial for pancreatic cancer. 

You may be eligible for this study if you were treated with the investigational algenpantucel-L (HyperAcute-Pancreas) immunotherapy in a clinical trial for pancreatic cancer (DRUG NLG-0205 or DRUG NLG-0405). 

Mulcahy, Mary FrancesMulcahy, Mary Frances
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206880
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Study Coordinator 312 695 1102
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NU MGH17C01: A single arm phase 2 study of the dual mTORC1/mTORC2 inhibitor AZD2014 provided on an intermittent schedule for patients with grade I-III meningiomas that recur or progress after surgery and radiation
The goal of this clinical research study is to learn if the study drug can shrink or sl…
The goal of this clinical research study is to learn if the study drug can shrink or slow the growth of meningioma. Treatment of meningioma cells in the laboratory has resulted in decreased survival of tumor cells. As such, the purpose of this research is to see whether treating your meningioma with the study drug will result in tumor size stabilization or shrinkage. The safety of the study drug will also be studied. Your physical state, your symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if the study drug is safe and effective in participants with your condition.
You may be eligible for this research study if you have one or more meningiomas which have grown or not responded to standard treatment.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03071874 STU00206421
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Study Coordinator 1 312 695 1102
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(xIRB NCI) ECOG-ACRIN 4151: A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
The purp…
The purpose of this research study is to determine whether an autotransplant improves survival in MCL patients who have achieved an excellent (MRD-negative) first complete remission (CR). An autotransplant is a procedure in which a high dose of chemotherapy is given, in hopes of reducing the amount of lymphoma more than what standard chemotherapy would generally accomplish. In order to allow the body to safely recover from the high-dose chemotherapy, blood stem cells are collected (prior to the high-dose chemotherapy) and then re-infused after the high dose chemotherapy is cleared from the body.
• Participants must be 18 years or older
• Participants must be diagnosed with mantle cell lymphoma, a type of blood cancer.
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03267433 STU00207302
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Study Coordinator 312 695 1102
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Partial Wave Spectroscopy for Urine Cytology Analysis
Bladder cancer is the fourth most common in men and sixth overall and while approximately 75% of patients will be diagnosed with superficial cancer, there is a high rate of recurrence. Currently, diagnosis and surveillance require invasive testing…
Bladder cancer is the fourth most common in men and sixth overall and while approximately 75% of patients will be diagnosed with superficial cancer, there is a high rate of recurrence. Currently, diagnosis and surveillance require invasive testing – cystoscopy (using a scope to look inside the bladder). While urine tests are used as part of the workup and follow-up, the current urine tests are limited. Our goal is to test a new technique that looks at individual cells to see if we can improve cancer detection. Cells that line the bladder are frequently shed into the urine, and therefore, these can be studied simply by providing a urine sample and without an invasive test. Our hope is that this urine test will be able to improve initial diagnosis and follow-up for patients with bladder cancer This is an investigational technique and is not approved by the USFDA.
Patients age 18-89 with a confirmed pathologic diagnosis of urothelial carcinoma of the bladder.
Meeks, Joshua JMeeks, Joshua J
STU00206508
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Meeks, Joshua J 312 695 8146
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Palbociclib after CDK and Endocrine Therapy (PACE): A Randomized Phase II study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

This research study is studying three combinations of drugs as treatments for this type of cancer:

  • Ar…

This research study is studying three combinations of drugs as treatments for this type of cancer:

  • Arm A: fulvestrant 
  • Arm B: fulvestrant with palbociclib 
  • Arm C: fulvestrant with palbociclib and avelumab 

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied and the researchers are trying to find out more about it— for example, the side effects it may cause, and the activity of a drug, or combination of drugs, against a cancer. 

In this research study, we are evaluating the activity of fulvestrant alone, fulvestrant and palbociclib, or fulvestrant, palbociclib, and avelumab in participants with metastatic hormone receptor positive breast cancer that has previously stopped responding to prior palbociclib therapy, or another medication in the class of therapy called CDK 4/6 inhibitors.

You may be eligible for this research study if you have breast cancer that has spread to other parts of your body (metastatic cancer) and your cancer is hormone receptor positive. This study is designed for patients who have previously had exposure to the medication palbociclib, or another medication in the class of therapy called CDK 4/6 inhibitors.

Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03147287 STU00207256
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Study Coordinator 1 312 695 1102
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NU UC18B01: PHASE IB/II OPEN-LABEL SINGLE ARM STUDY TO EVALUATE SAFETY AND EFFICACY OF TUCATINIB IN COMBINATION WITH LETROZOLE AND PALBOCICLIB IN SUBJECTS WITH HORMONE RECEPTOR POSITIVE AND HER2-POSITIVE METASTATIC BREAST CANCER

This study plans to learn more about the combination therapy of tucat…

This study plans to learn more about the combination therapy of tucatinib with palbociclib and letrozole and how these drugs work together to treat HR+/HER2+ metastatic breast cancer. The purpose of the study is to evaluate the safety and how well the study drugs are tolerated when given in combination.

Letrozole has been approved as standard treatment for metastatic breast cancer by the U.S. Food and Drug Administration (FDA). Palbociclib has been approved by the FDA for treatment of hormone receptor positive (HR+) metastatic breast cancer, but has not yet been approved for patients with HR+ and HER2+ metastatic breast cancer. Tucatinib has not been approved for treatment in metastatic breast cancer patients. This is considered an “investigational” study because this combination of drugs has not been approved by the FDA. 

You may be eligible for this research study if you have been diagnosed withHR+/HER2+ metastatic breast cancer. 
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03054363 STU00207287
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Study Coordinator 312 695 1102
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DRUG GRN-1201-002: A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 Expression

This is the first study of GRN-1201/sargramostim in combination with pembrolizumab in humans. The researchers want to fin…

This is the first study of GRN-1201/sargramostim in combination with pembrolizumab in humans. The researchers want to find out what effects, good or bad, this combination has on people with newly diagnosed metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 and whose tumor biopsy samples express PD-L1. 

The study drug, GRN-1201, is a type of cancer vaccine made up of four peptides (short chains of amino acids) that can cause an immune system response against cancer cells. The study drug is being tested when it is added to another drug called pembrolizumab, an approved medicine to treat NSCLC which has spread (metastatic), because it may cause a response by the immune system against the tumor. GRN-1201 is considered an "investigational" drug. An investigational drug is one that is not approved by the Food and Drug Administration (FDA) for use or sale in the United States. Each dose of GRN-1201 will be 3.0 mg of each peptide given together with a low dose (75 mcg) of another drug called rhGM-CSF (sargramostim, also called Leukine®). Sargramostim is an FDA approved drug which may enhance (increase) your body's immune response to GRN-1201. GRN-1201/sargramostim in combination with pembrolizumab has not been tested before and is not FDA approved. 

You may be eligible for this research study if you have newly diagnosed metastatic non-small cell lung cancer (NSCLC) with high levels of PD-L1. 
Villaflor, VictoriaVillaflor, Victoria
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03417882 STU00206591
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Study Coordinator 1 312 695 1102
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A multicenter, randomized, double-blinded, placebo-controlled, phase 3 trial of adjuvant Avelumab (anti-PD-L1 antibody) in Merkel cell carcinoma patients with clinically detected lymph node metastases

The purpose of this study is to find out how the study drug, Avelumab (anti-PDL-1, also called MS…

The purpose of this study is to find out how the study drug, Avelumab (anti-PDL-1, also called MSB0010718C), works in subjects who have Merkel Cell Carcinoma (MCC) that has traveled to lymph nodes. Avelumab is being tested to see if it is given after surgery and radiation, if it might prevent the cancer from coming back. Avelumab is currently approved by the Food and Drug Administration for the treatment of advanced and metastatic MCC. This FDA approval of avelumab for patients with advanced MCC was granted on the basis of a phase II study showing activity when given after progression of disease on chemotherapy. However, avelumab is an experimental drug in this study and it has NOT been approved for treatment of MCC that has traveled to the lymph nodes (node-positive, non-metastatic MCC) that has been removed with surgery. Avelumab has not been tested in this setting before.

Avelumab is an antibody. An antibody is a type of protein thought to work by helping the immune system fight against cancer cells. In this study, we want to compare the study product to placebo (like normal saline) to learn if the study drug might keep your cancer from coming back after you have had surgery and radiation to remove it. We are using a placebo to make sure that the information we collect is not biased or “skewed”. This is considered acceptable because no drug is known to keep your cancer from coming back. If you join this study, you would receive either avelumab or placebo. You would not get both.

You may be eligible for this research study if you have Merkel Cell Carcinoma (MCC) that has traveled to your lymph nodes. You must have completed treatment that included surgical removal of the cancer.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03271372 STU00207190
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A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause n…

The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause normal and cancerous cells to grow and multiply. While sorafenib is an effective drug for treating HCC, there is evidence suggesting that combining sorafenib therapy with pembrolizumab may be more effective than sorafenib by itself. 

Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat HCC. Pembrolizumab works by helping the immune system to fight cancer. However, pembrolizumab can also cause the immune system to attack normal organs and tissues in the body and can affect the way they work, which can result in side effects that may become serious or life-threatening, and in some cases, may lead to death. 

The purpose of this study is to test the safety of giving pembrolizumab in combination with sorafenib, and to look at the effect that this combination has on HCC and how it responds to this treatment.

You may be eligible for this research study if you have hepatocellular carcinoma (HCC), which is the most common type of liver cancer and usually occurs with chronic liver disease. 

Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03211416 STU00207399
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A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585).
The purpose of this s…
The purpose of this study is to test the safety, efficacy, and tolerability of the research study drug, pembrolizumab (MK-3475) in combination with cisplatin and capecitabine or 5- fluorouracil (5-FU).

You may be eligible for this research study if you have gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03221426 STU00207611
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Study Coordinator 1 312 695 1102
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A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Hematological Malignancies) and Phase 2 (Dose Expansion of CPI- 0610 with and without Ruxolitinib in Patients with Myelofibrosis)

The purpose of this study is to find ou…

The purpose of this study is to find out if an investigational drug called CPI-0610 can help with myelofibrosis. An investigational drug is a drug that is not approved for sale in the United States by the Food and Drug Administration (FDA). 

This study evaluates CPI-0610 in patients who have both received JAK inhibitors, such as ruxolitinib (Arms 1 and 2), and in patients who have never been treated with a JAK inhibitor (Arm 3). Patients who participate in Arm 1 will be treated with CPI-0610 alone (monotherapy arm), patients who participate in Arm 2 will be treated with CPI-0610 in combination with ruxolitinib (combination arm), and patients who have never been treated with a JAK inhibitor who participate in Arm 3, will also be treated with CPI-0610 and ruxolitinib, a JAK inhibitor (JAKi naïve arm). Your assignment to one of the arms will be based on your previous treatment history and how you responded to those medications. 

You may be eligible for this research study if you have been diagnosed with myelofibrosis, a bone marrow disorder that disrupts your body’s normal production of blood cells.

Stein, Brady LeeStein, Brady Lee
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02158858 STU00207387
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Protocol ATI001-102 Expansion Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects with Recurrent or Progressive Glioblastoma
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-…
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02026271 STU00207771
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Amidei, Christina 312 695 9124
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Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination with R-CHOP in a Cohort of Patients with DLBCL/tFL/ high grade B-NHL

The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffu…

The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffuse large B-cell lymphoma (DLBCL). 

The standard chemotherapy regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is called “R-CHOP” and includes the drugs: Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O) and Prednisone (P). The new drug, nivolumab, works by targeting the immune system and increasing the effect of immune cells against the cancer cells. 

The purpose of the study is to determine if the combination of nivolumab with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth, and whether or not it improves symptoms and quality of life in those who participate in the study. 

Nivolumab is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer. However, it has been studied and approved by the FDA for other types of cancer.

    You may be eligible for this research study if you have been diagnosed with aggressive diffuse large B-cell lymphoma (DLBCL) or another form of aggressive B-cell non-Hodgkin lymphoma, and you have not been treated for this type of cancer.

    Karmali, ReemKarmali, Reem
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03704714 STU00207793
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    Study Coordinator 312 695 1102
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    NU 18U07: Clinical, Environmental, Genetic and Genomic Profile of Men with Early-Onset Aggressive Prostate Cancer

    This study is being done because physicians do not completely understand the progressive biology of prostate cancer. Hence, the study aims to gather a better understanding of the clini…

    This study is being done because physicians do not completely understand the progressive biology of prostate cancer. Hence, the study aims to gather a better understanding of the clinical and molecular features of prostate cancer patients who are younger than or equal to 60 years of age.

    In this research project the researchers aim to characterize the different clinical, environmental, genetic and genomic profiles of men who present with early-onset (less than 60 years old) metastatic prostate cancer that spread to either lymphnodes or other parts of the body at diagnosis or who develop metastases shortly after local therapy. Specifically the investigators will collect information on race, ethnicity, family history, environmental, hormonal levels, metastatic disease extent and distribution. They will also evaluate the tumor tissue for genetic changes and correlate that with other clinical factors. The investigators will also determine if there are inherited genetic changes. Similarly for patients with spread prostate cancer who were treated with hormone therapy + docetaxel or abiraterone/prednisone with cancer progression (less than 1 year from start of therapy) and developed disease progression the investigators will assess clinical and genomic predictors of prostate cancer progression and resistance to therapy.

    You may be eligible for this study if you are a male who has been diagnosedwith either advanced or metastatic prostate cancer. Advanced means that the cancer has spreadoutside the prostate gland including pelvic lymph nodes and metastatic means that the cancerhas spread to other parts of your body. 

    One group of participants will be less than 60 years ofage with advanced or metastatic prostate cancer at diagnosis and the other group will be menwho have metastatic prostate cancer who were treated with hormone therapy with docetaxel orabiraterone/prednisone and the cancer is progressing.

    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207711
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    Study Coordinator 1 312 695 1102
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    (xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
    The first purpose of this study is to te…
    The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
    You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
    Dinner, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03150693 STU00208162
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    Study Coordinator 312 695 1102
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    A phase 1 study of R-CHOP plus SYK inhibitor TAK-659 for the front-line treatment of high-risk diffuse large B cell lymphoma (DLBCL)

    We are performing a clinical trial that will combine 1 new drug, TAK-659, with a standard treatment regimen for diffuse large B-cell lymphoma (DLBCL). The stand…

    We are performing a clinical trial that will combine 1 new drug, TAK-659, with a standard treatment regimen for diffuse large B-cell lymphoma (DLBCL). The standard treatment regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is a chemotherapy combination called R-CHOP (Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O), Prednisone (P)). The new drug, TAK-659, inhibits the activity of a protein called Syk, which is known to function abnormally in this type of cancer. 

    The purpose of the study is to make sure that the combination of TAK-659 with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth and improving your symptoms. 

    TAK-659 is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer.

    You may be eligible for this research study if you have been diagnosed with diffuse large B-cell lymphoma (DLBCL), you have not been treated for your cancer, and your doctor plans to treat you with the R-CHOP chemotherapy regimen.

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03742258 STU00207880
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    Study Coordinator 312 695 1102
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    NU 18U08: Targeting Chemokine Signaling and MAPK/ERK Pathway in Advanced Prostate Cancer

    This is an observational study in which no treatment decisions will be made based on the findings of this study. This study is being done because physicians do not completely understand the progressive biology…

    This is an observational study in which no treatment decisions will be made based on the findings of this study. This study is being done because physicians do not completely understand the progressive biology of prostate cancer. Hence, the study aims to gather a better understanding of some specific biomarkers (molecular markers) and their relation to the clinical picture of prostate cancer patients. The researchers aim to collect blood samples which will be used to evaluate biomarkers in Circulating Tumor cells (CTCs) and correlate their expression to disease prognosis (the likely course your disease will take) and response to therapy. They will collect information including age, race, ethnicity, family history of prostate cancer and other cancers, prostate cancer grade, tumor treatment, response to treatment, duration of survival and metastatic disease extent and distribution. 

    A patient may be eligible for this research study if he has metastatic prostate cancer for which he will start hormone therapy (androgen deprivation therapy [ADT] plus abiraterone [Zytiga] if the cancer is castration sensitive, or with abiraterone or enzalutamide [Xtandi] if the cancer is castration resistant).

    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207694
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    Study Coordinator 1 312 695 1102
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    A Study To Estimate the Anti-Tumor Activity And Identify Potential Predictors of Response in Patients with Advanced Mucosal or Acral Lentiginous Melanoma Receiving Standard Nivolumab in Combination with Ipilimumab followed by Nivolumab Monotherapy.

    This is a study to learn more about mucosal and a…

    This is a study to learn more about mucosal and acral lentiginous melanoma therapy. We are collecting blood and tissue samples from people who will receive nivolumab in combination with ipilimumab treatment for their mucosal and acral lentiginous melanoma. The nivolumab and ipilimumab combination is approved by the U.S. Food and Drug Administration for the treatment of patients with advanced melanoma and therefore is considered a standard treatment of this disease.

    However, the disease we call melanoma can present in different fashions, which may influence its behavior and response to therapy. Melanomas that start on mucous membranes are called mucosal and those that develop on the palms and soles of the feet are designated “acral lentiginous.” These rare subtypes of melanoma may behave differently from the more common melanomas that begin on sun exposed skin surfaces. Research on blood, tissues, and medical information is one way to learn more about diseases. We can learn how different people respond to different cancer treatments.

    The purpose of this study is to determine which participants with melanoma respond best to nivolumab and ipilimumab treatment and to identify tumor and blood based markers that may predict response to the combination. To do this, participants will be asked to submit tumor tissue samples from initial tumor specimen and blood samples before and during treatment with nivolumab and ipilimumab for their advanced melanoma. By collecting participant information on response to therapy and correlating it with analyses of blood and tumor samples we hope to determine which patients are most appropriate for this treatment and potentially factors that might suggest patients should be considered for a different treatment.

    You may be eligible for this research study if you have been diagnosed with mucosal and/or acral lentiginous melanoma.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02978443 STU00207669
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    Study Coordinator 1 312 695 1102
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    DRUG D6070C00004: A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC

    This study is being conducted to test 2 experimental drugs, oleclumab (MEDI9447) and osimertinib, given in combination (tog…

    This study is being conducted to test 2 experimental drugs, oleclumab (MEDI9447) and osimertinib, given in combination (together), to treat advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC). 

    Oleclumab is a laboratory-made antibody that binds to a molecule called CD73. Naturally occurring, antibodies are proteins, made by the immune system, that fight infections and other diseases. The immune system can recognize cancer cells, and in some circumstances control or even eliminate tumors. In the body, CD73 produces a molecule called adenosine. Too much adenosine can suppress the activity of the immune system. Oleclumab binds to CD73, reducing CD73’s ability to produce adenosine. This reduction in adenosine may boost the activity of the immune system, and prevent cancer growth. Additionally, it has been shown that patients with EGFRm NSCLC have higher levels of the CD73 protein in their tumors compared to patients with lung cancer that lacks the mutation in the EGFR gene. Osimertinib blocks the actions of a protein in the body called tyrosine kinase. It has been approved by the United States Food and Drug Administration (FDA) for the treatment of a type of EGFRm NSCLC that is linked to a specific change in the EGFR gene called the T790M mutation. The use of osimertinib is “experimental” in this study because the use of osimertinib combined with oleclumab as a cancer treatment has not been approved by any authority that regulates new medicines. This means that treatment with osimertinib is not standard care for treating this type of cancer. 

    The study will look at whether this combination of oleclumab and osimertinib, because of the way they work, may improve the outcome in subjects with your type of cancer. The purposes of this study are to find the doses of oleclumab and osimertinib, given in combination, which are safe and well tolerated, to determine what side effects may occur and to confirm how well the treatment works for EGFRm NSCLC. The study will also measure the amount of oleclumab and osimertinib in your blood at various times, whether or not your body makes antibodies against oleclumab, and the effect oleclumab combined with osimertinib has on your cancer. Antibodies against oleclumab could reduce the active level of the study drugs in your blood and reduce the effects of the study drugs on your cancer.

    You may be eligible for this research study if you have advanced epidermalgrowth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and your cancer is advanced and is worsening despite previous treatments that have included a medicine whichworks to block the EGFR gene.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03486314 STU00207982
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    Study Coordinator 1 312 695 1102
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    A Phase 1, First in Human, Open Label, Dose Escalation Study of AMV564, a CD33 x CD3 Tandem Diabody in Patients with Relapsed or Refractory Acute Myeloid Leukemia

    This is the first in human study to test an investigational drug called AMV564. AMV564 has not been approved by the Food and Drug Admin…

    This is the first in human study to test an investigational drug called AMV564. AMV564 has not been approved by the Food and Drug Administration (FDA) in the United States or any health or regulatory authority in other countries. 

    The purpose of this clinical research study is to find the highest tolerable dose of this drug that can be given to subjects with acute myeloid leukemia (AML), and to recommend a dose to be used in future studies. Another purpose of the study is to learn more about the safety of this drug and how the body processes the drug. For example, the study will look at how long the drug can be measured in the blood, and how the drug affects AML cancer cells and other blood cells.

    You may be eligible for this research study if you have acute myeloid leukemia(AML), a blood cancer that has either returned, worsened or is resistant to treatment.

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03144245 STU00207464
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    Study Coordinator 312 695 1102
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    Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)

    The purpose of this study is to:

    - See how well the study drug, pembrolizumab, works compared to placebo in keeping your cancer from coming back …

    The purpose of this study is to:

    - See how well the study drug, pembrolizumab, works compared to placebo in keeping your cancer from coming back or spreading. A placebo looks like the study drug but has no medicine in it.

    - Test the safety of the study drug

    - See how your body handles the study drug.

    - Male/female patients at least 18 years of age who have surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma

    - Patients must not have been previously treated for melanoma beyond complete surgical resection of the current primary melanoma lesion

    - Patients must be able to start study treatment no more than 12 weeks after full surgical resection.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03553836 STU00208266
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    Study Coordinator 312 695 1102
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    NU 18I01: A Phase 2 study of pembrolizumab in combination with pelareorep in patients with advanced pancreatic adenocarcinoma
    This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Fo…
    This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any effect on pancreatic cancer and also to evaluate the safety ofthis combination of these two drugs. Pelareorep is an investigational product that uses a type ofvirus called reovirus. This virus is commonly found in natural environments throughout the world(such as ponds) and is associated with minor breathing difficulties and stomach upsets inhumans. Infection of cancer cells by this virus is expected to be able to slow cancer lesiongrowth and kill cancer cells.  Pembrolizumab is a drug thatworks on stimulating the immune system to fight the cancer cells and it is currently approvedfor the treatment of other tumors (melanoma and lung). It is not presently known if it will help inthe treatment of pancreatic cancer. The combination of pembrolizumab and pelareorep isexpected to be able to determine if pelareorep will or will not stimulate the immune systemand make it more responsive to therapy with pembrolizumab.
    Participants with advancedpancreatic adenocarcinoma.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03723915 STU00207577
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    Study Coordinator 312 695 1102
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    DRUG CX-839-008: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination with Cabozantinib (CB-Cabo) vs. Placebo with Cabozantinib (Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

    The purpose of this study is to determine i…

    The purpose of this study is to determine if CB-839 (an “investigational” drug), given together with cabozantinib (an “approved” drug), is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than cabozantinib alone. This study will also look at any possible effect that CB-839 in combination with cabozantinib may have on your cancer.

    "Investigational" means that CB-839 has not been approved by the United States Food and Drug Administration (FDA) or any other health authority in the world for use outside of research studies. “Approved” means that cabozantinib has been tested and approved for sale by the FDA (and other health authorities) and can be prescribed by doctors. The combination of CB-839 together with cabozantinib is also investigational.

    You may be eligible for this research study if you have kidney cancer. 
    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03428217 STU00208112
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    Study Coordinator 312 695 1102
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    DRUG ASTX660-01: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

    The purpose of the study is to test the safety of the study drug ASTX660 and to see if this drug has an effect on treating your cancer. The dru…

    The purpose of the study is to test the safety of the study drug ASTX660 and to see if this drug has an effect on treating your cancer. The drug that will be given to you in this study is investigational, meaning that it has not yet been approved for treatment of any disease, including cancer.

    Cancer is a disease involving the uncontrolled growth of human cells. Normal cell growth is controlled by many mechanisms. Cancer cells escape these mechanisms and grow uncontrollably. One of the ways that cancer cells continue to grow is by producing proteins called "Inhibitors of apoptosis proteins (IAPs)" that block the normal cell death pathway of human cells. The study drug may interfere with the function of these inhibitory proteins and thus cause the cancer cells to die or stop growing.

    You may be eligible for this research study if you have an advanced cancer that is either a solid tumor or blood cancer and it has not responded to treatment with other therapies.

    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02503423 STU00208005
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    Study Coordinator 312 695 1102
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    A multicenter Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of the combination of rogaratinib and copanlisib in patients with FGFR-positive, locally advanced or metastatic solid tumors

    There are two con…

    There are two consecutive parts to this study, a dose escalation part and a dose expansion part.

    The purpose of the escalation part is to determine the highest dose that can be safely given of the study drugs (Rogaratinib) in combination with Copanlisib to treat follicular lymphoma that has come back to participants with locally advanced or metastatic solid tumors. The aim of this part of the study is to determine the appropriate dose of Rogaratinib to be used in combination with Copanlisib. Approximately 15 patients may be treated during this first part of the study.

    Once the appropriate dose of Rogaratinib and Copanlisib in combination has been defined, the expansion part of the study will start and approximately up to 30 additional patients will be treated. The purpose of this part is to assess whether or not the selected dose of the combination is safe and shows activity in treating participants with locally advanced or metastatic urothelial carcinoma (a type of cancer that occurs in the urinary system, including bladder, urethra, ureter or renal pelvis).

    Rogaratinib is an investigational drug, which means that it has not been approved by any country’s health authority and it is only available to people who are in research studies. It is made and studied by Bayer for the treatment of cancer that belongs to a new class of medication called tyrosine kinase inhibitors. A tyrosine kinase inhibitor targets certain key structures called proteins in or on the surface of your cells that are needed for the survival of the cancer cells. The study drug targets a class of tyrosine kinases called fibroblast growth factor receptors (FGFR). Therefore, these drugs work by stopping the cell growth of cancer cells in a specific way and may even reduce the size of the tumor.

    The test drug Copanlisib has already been approved by the FDA (Food and Drug Administration) in the US for the treatment of adult patients with relapsed follicular lymphoma, but not other type of cancers. Copanlisib works by inhibiting the cell growth of the cancer via a specific pathway. This drug blocks the enzyme Phospho-Inositol-3-Kinase (PI3K), which stimulates the growth of tumor cells. 

    Concomitant administration of study test drugs Rogaratinib with Copanlisib has never been used before this study. 

    You may be eligible for this research study if you have been diagnosed with locally advanced or metastatic solid tumors.

    Fibroblast Growth Factor Receptor (FGFR; a protein found abnormally present on the surface of some cancer cells) testing (tissue test) is required to see if you qualify for the study.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03517956 STU00208211
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    Study Coordinator 312 695 1102
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    A Phase 2, Randomized, Biomarker-driven, Clinical Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML and Exploratory Arms with Varying Levels of MCL-1 Dependence

    The purpose of this research study is to …

    The purpose of this research study is to determine the effectiveness (how well something works) and safety of an “investigational” compound called alvocidib when used in a combination chemotherapy regimen in patients with acute myeloid leukemia (AML) who have varying levels of MCL-1 (human gene) dependency. “Investigational” means that the Food and Drug Administration (FDA) has not yet approved this drug as a prescription medicine; it is only available through research studies like this. 

    Alvocidib was previously known as flavopiridol. Alvocidib is an investigational product being developed by Tolero Pharmaceuticals in AML. Alvocidib will be one of three drugs used in the combination chemotherapy treatment regimen. The other drugs are cytarabine and mitoxantrone. Both cytarabine (also known as Ara-C) and mitoxantrone are standard of care for the treatment of patients with AML. However, the three-drug combination of alvocidib with cytarabine and mitoxantrone (abbreviated “ACM”) is an experimental combination. (ACM has also been referred to as FLAM).

    You may be eligible for this research study if you have acute myeloid leukemia (AML) that has come back after initial treatment (relapsed) or because you did not get a complete response from your initial treatment (refractory) or you have been newly diagnosed with highrisk (NDHR) AML. As part of the initial pre-screening process, you had a bone marrow aspirate performed and tested that showed you have AML that expresses a protein that may predict whether you will respond to treatment with ACM (an experimental combination).

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02520011 STU00208084
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    Study Coordinator 312 695 1102
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    NU C18C01: A Phase I Study of Safety and Tolerability of Acetazolamide with Temozolomide in Adults with Newly Diagnosed MGMT Promoter-Methylated Malignant Glioma

    This study is being done to learn more about a combination of two drugs called acetazolamide and temozolomide given to persons who have …

    This study is being done to learn more about a combination of two drugs called acetazolamide and temozolomide given to persons who have an aggressive form of glioma (either grade III or IV). We aim to explore whether it is possible to add acetazolamide to a standard treatment regimen of temozolomide and radiotherapy. Specifically, the study will explore whether the study drug combination (the addition of acetazolamide to the temozolomide regime) will cause negative side effects that would not be seen in someone just receiving temozolomide alone. Some subjects on the trial may experience important or serious side effects. If certain side effects are seen, the study drug combination will be stopped.

    Temozolomide and acetazolamide given together is experimental in this study and is not FDA approved. It is thought that acetazolomide may make the standard temozolomide chemotherapy more effective in a subset of patients.

    You may be eligible for this research study if you have newly diagnosed glioma, a form of brain cancer.

    Lukas, RimasLukas, Rimas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03011671 STU00208331
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    Study Coordinator 1 312 695 1102
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    A Randomized Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma

    In the study, the treatment period is divided into cycles that are 4 weeks long.Relatlimab/nivolumab FDC or nivolumab alone…

    In the study, the treatment period is divided into cycles that are 4 weeks long.Relatlimab/nivolumab FDC or nivolumab alone will be given once every 4 weeks (every 28 days) of each treatment cycle.Participants will continue to receive treatment depending on how they tolerate the study drug(s) and how their cancer responds. After completing all study treatments or after the treatment has been stopped for other reasons, participants will be asked to continue with follow-up visits to monitor for potential benefits or side effects they may be experiencing from study treatment.  Participants may be followfor up to 5-7 years total.   

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03470922 STU00207656
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    Study Coordinator 312 695 1102
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    DRUG E7080-G000-604: An open-label, multi-center, roll-over study to assess long term safety of lenvatinib monotherapy or lenvatinib combination regimen or comparator treatment arm to cancer patients in Eisai sponsored lenvatinib trials

    The purpose of this study is to gather long term safety on le…

    The purpose of this study is to gather long term safety on lenvatinib as either monotherapy or in combination therapy. If you received comparator drug in the previous study you will continue to receive that drug at the same dose. This will allow you to continue at your current dose of the study drug(s) until loss of clinical benefit or until disease progression as confirmed by your doctor, unacceptable toxicity, withdrawal by your own request, consent withdrawal, or study termination by the sponsor. Monitoring of hematology, blood chemistry, and urine values, and performance of physical examinations will be performed per standard of care or as clinically indicated.

    You may be eligible for this research study if you have been diagnosed with cancer and you have participated in a clinical trial in which you have received the study drug lenvatinib. The current study that you are participating in, called the parent study, will be ending and this new study will allow you to continue to receive the drug you received previously in addition to following any side effects that may occur in the future.

    Agulnik, MarkAgulnik, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03477175 STU00207974
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    Study Coordinator 312 695 1102
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    DRUG GC P#05.01.020: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
    The main purpose of this study…
    The main purpose of this study is to determine whether NiCord® transplants are better than transplants with standard, unmanipulated cord blood units.
    You may be eligible for this study if you have a blood cancer that is being treated with allogeneic stem cell transplantation. 
    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00208388
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    Study Coordinator 312 695 1102
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    An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

    This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Prog…

    This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Program is to give access to the investigational drug, ruxolitinib, to graft-versus-host disease (GVHD) patients in the United States who are not eligible or able to participate in clinical trials. 

    A second objective is to monitor the safety of ruxolitinib in GVHD patients. 

    Ruxolitinib is an investigational drug that is being studied for use in the treatment of GVHD. “Investigational” means that ruxolitinib has not been approved by the FDA (Food and Drug Administration) for use as a prescription or over-the-counter medication.

    You may be eligible for this research study if you have acute or chronic graft-versus-host disease (GVHD) but are not eligible or able to obtain ruxolitinib by participating in clinical trials.

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03147742 STU00208471
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    Study Coordinator 312 695 1102
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    (xIRB NCI CIRB) Alliance A011401: Randomized Phase III Trial Evaluating The Role Of Weight Loss In Adjuvant Treatment Of Overweight And Obese Women With Early Breast Cancer
    This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have fou…
    This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have found that women who are overweight or obese when their breast cancer is found have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether or not losing weight will reduce the risk of breast cancer returning. This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost. It is important to note that we do not know how much weight would need to be lost to lower the risk of breast cancer recurrence, or whether this strategy would work for all women. This study willhelp to show researchers whether weight loss programs should be a part of breast cancer treatment.

    This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost.

     

    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00208895
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    Study Coordinator 312 695 1102
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    ECOG-ACRIN 6174: A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma (NCT)

    We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, di…

    We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, andtreat diseases like cancer.This study is being done to answer the following question: Can we lower the chance of your cancer growing back by adding a study drug after your surgery?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your Merkel Cell Carcinoma. The usual approach is defined as care most people get after surgery to remove the cancer.

    We are asking you to take part in this research study because you have stage I-IIIB Merkel Cell Carcinoma (MCC) that has been removed by surgery.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03712605 STU00208944
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    Study Coordinator 312 695 1102
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    Utilization of Clinomic Outcomes, Patient-Derived Xenografts (Avatars), and Next Generation Sequencing Data for the Identification of Alternative Actionable Targets and Therapeutic Response Prediction in Cholangiocarcinoma

    The purpose of this study is to gather information about your cancer and th…

    The purpose of this study is to gather information about your cancer and the genetic makeup of your tumor tissue. In this study, we are looking for specific biomarkers using genetic testing and animal models. We are interested in learning about the relationship between your cancer and the different types of genetic markers in your tumor tissue to identify possible new treatment methods in the future. 

    A portion of your tumor will be sent for routine genomic analysis. The tests known as next generation sequencing or “NGS” are being done on your cancer tissue samples as part of your routine clinical care. These routine tests will be performed whether you participate in this study or not. Another small portion of that tumor will be placed in a mouse to grow (xenograph or “avatar”) from which more genetic analyses will be performed. 

    You may be eligible for this research study if you have a diagnosis of a type of cancer called cholangiocarcinoma, and you are planning to have either a surgical resection or a biopsy of your tumor at Northwestern University, in which you agree to have a portion of your tumor sent for routine genomic analysis to potentially help you and your physician make treatment decisions now or in the future. 

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00208589
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    Study Coordinator 1 312 695 1102
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    NU 18I03: Pilot study of nivolumab in combination with Therasphere (yttrium-90) for treatment of hepatocellular carcinoma (HCC) with intent for resection
    The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your…
    The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your HCC from coming back. Also another purposeis to evaluate the efficacy (the effect on the tumor) of nivolumab, when given with standard ofcare Y-90 (Therasphere) in patients. Another purpose of the study is to see what tumor characteristics are different among patientswho undergo resection versus those who do not undergo resection. 
    Participants who have advancedhepatocellular carcinoma (HCC). 
    Kulik, Laura MKulik, Laura M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03812562 STU00208542
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    Study Coordinator 312 695 1102
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    A Phase 1/2, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome
    This study involves research about the…
    This study involves research about the study drug MGD006. MGD006 is similar to an antibody - a substance in the blood that helps remove foreign substances. MGD006 is made to attach to your cancer cells and to T-cells - a part of your immune system - that may help your immune system kill the malignant cells. MGD006 is an investigational drug which means it has not been approved by the Unites States Food and Drug Administration (FDA) for the treatment of AML or any other cancers. MGD006 has been tested in animals, but this is the first time it will be given to humans to be tested as a possible treatment for AML. The purpose of this study is to find the answers to these research questions:

    • What are the side effects of MGD006?
    • What is the highest dose of MGD006 that can be given safely?
    • How long does MGD006 stay in the blood?
    • How long does it take for MGD006 to leave the body?
    • Is MGD006 a possible treatment for AML?

    • Patients must have a confirmed diagnosis of primary or secondary AML or MDS with a risk category of Intermediate-2 or High Risk
    • Patients must be unlikely to benefit from recommended standard of care defined by any one of the following criteria:
      • leukemia refractory to at least 2 induction attempts,
      • leukemia in 1st relapse with initial CR duration < 6 months
      • leukemia in 1st relapse following at least 1 unsuccessful salvage attempt
      • leukemia in 2nd or higher relapse
      • prior treatment failure with at least four cycles of a hypomethylating agent
    • Patients with MDS must have experienced treatment failure with induction therapy or at least one cycle of hypomethylating therapy and have at least 10% bone marrow blasts.
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00208838
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    Study Coordinator 312 695 1102
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    DRUG JZP963-201: A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

    Allogeneic hema…

    Allogeneic hematopoietic stem cell transplant (HSCT) involves the receipt of healthy bone marrow or stem cells from a donor in order to replace damaged bone marrow stem cells. A common complication of allogeneic stem cell transplant is acute Graft versus Host Disease (abbreviated as aGvHD). It occurs in close to 40–59% of patients who receive allogeneic HSCT, and it may be life threatening. The donated tissue you will receive contains healthy cells that will repopulate your marrow and produce healthy blood cells. The donor graft tissue also contains immune cells which help to recognize and destroy the few, if any, remaining leukemia or preleukemic cells remaining in your body. But these donor immune cells can also sometimes attack your body because the immune cells from the donor graft are different from yours and they recognize your cells (called ‘the host’) as foreign. The immune cells from the graft start an immune reaction which can affect multiple organs in your body. This is what happens in aGvHD. All patients who undergo allogeneic HSCT receive medicine to try to prevent aGvHD. These prophylactic treatments work by suppressing (decreasing) the activity of the immune cells, and they are therefore called immunosuppressive regimens or immunoprophylaxis. Most of the prophylactic treatments that are used prevent some, but not all, aGvHD. Despite the use of immunosuppressive regimens, aGvHD remains the most important and life-threatening complication after HSCT.

    This clinical research study will test a study drug designed to prevent acute Graft-versus-HostDisease (aGvHD) by adding this new medicine to the usual medicines your doctor will give you for prevention of aGvHD. Everyone who participates in the study will receive treatment to prevent aGvHD, but some of the participants will also receive defibrotide, the study drug being studied in this trial, while some of the participants will not receive the study drug. 

    The study is being done to learn if adding defibrotide to the standard medicines for prevention of aGvHD, which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. In GvHD, when the immune cells from the graft begin to recognize a patient’s tissue as foreign and start to attack normal tissue, it is because they have been sent a signal to do so by certain chemicals in the body called inflammatory cytokines. Defibrotide has been shown to reduce the levels of some inflammatory cytokines. It has a protective effect on cells lining the blood vessels, and might have the potential to prevent early immune reactions after stem cell transplantation.

    Defibrotide is used in adults and children to treat liver Veno Occlusive Disease (VOD) when there is also kidney or lung dysfunction (also known as severe VOD) following HSCT. Defibrotide has been approved for this treatment in Europe, Israel, South Korea, the United States, and Canada with the brand name Defitelio®. The study drug has not been approved for the prevention of aGvHD in patients undergoing HSCT. Its use in this study is experimental.

    You may be eligible for this research study if you have been diagnosed with acute leukemia or with myelodysplastic syndrome (MDS), and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). To be eligible, study participants must be identified to be at high risk for developing acute graft-versus-host disease (abbreviated as aGvHD), a common complication of allogeneic stem cell transplant. 

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03339297 STU00208805
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    Study Coordinator 312 695 1102
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    An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

    This study will test if low-dose oral minoxidil has aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy re…

    This study will test if low-dose oral minoxidil has aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy regimen that persists for over six months). Inthis study, you will receive the study drug; there is no placebo option. Theeffectiveness and safety of the treatment will be determined by a range of assessments,including biopsies, images, and subjective evaluation of perceived hair growth.

    Age 18 and above with a diagnosis of permanentchemotherapy-induced alopecia and agree to use contraception for the durationof the study.

    Choi, JenniferChoi, Jennifer
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03831334 STU00206882
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    Kosche, Cory 312 503 5944
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    A Phase II Randomized Study of Adjuvant Versus Neoadjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High Risk Melanoma

    This study is being done to answer the following question: How does treating melanoma with the study drug pembrolizumab, before versus after surgery affect t…

    This study is being done to answer the following question: How does treating melanoma with the study drug pembrolizumab, before versus after surgery affect the disease?

    We are doing this study because we want to find out which approach is better for treating high-risk melanoma. If you decide to take part in this study, you will eitherget treatment with pembrolizumab after your surgery, or you will be treated withpembrolizumab for a few weeks before surgery, then undergo surgery, and getmore pembrolizumab after your surgery.After you finish your study treatment, your doctor willcontinue to follow your condition for up to 10 years after you register to thestudy.  Your doctor will watch you forside effects and to see how your cancer affects you.  You will have clinic visits periodically fromthe time you stop taking treatment until 10 years after you register to the study.

     

    We are asking you to take part in this research study because you have melanoma which is ready for removal by surgery.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03698019 STU00209408
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    Study Coordinator 312 695 1102
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    DRUG 16-214-02 A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF THE COMBINATION OF NKTR-214 AND NIVOLUMAB OR THE COMBINATION OF NKTR-214, NIVOLUMAB, AND OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH SELECT LOCALLY ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
    This is an investigational study of a drug …
    This is an investigational study of a drug named NKTR-214 that will be given in combination with Opdivo® (nivolumab) or in combination with Opdivo® and other anti-cancer therapies. NKTR-214, also referred to as “study drug,” is a modified (changed in the laboratory) form of a protein called interleukin-2 (or IL-2) that is normally made by your immune system. This protein is designed to trigger other cells in your immune system to start attacking your cancer cells. IL-2 has been used for certain cancers for many years so doctors understand many of the risks and benefits.

    We are asking you to take part in this research study because you have a diagnosis of: Melanoma (skin cancer). Here at Northwestern University we will only be enrolling participants who have been diagnosed with Melanoma.

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02983045 STU00208952
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    Study Coordinator 312 695 1102
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    DRUG U31402-A-J101: Phase 1/2, Multicenter, Open-label, Multiple Dose First-In-Human Study of U3-1402, in Subjects with HER3 Positive Metastatic Breast Cancer
    In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous trea…
    In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous treatments. The purpose of the study is tounderstand U3-1402 for its safety, how well it works, and how well it is tolerated.U3-1402 is an investigational drug being developed to be given in breast cancer. Aninvestigational drug is a medication that has not been approved by the United States (US) Foodand Drug Administration (FDA). The FDA allows U3-1402 to be used only in research.U3-1402 is a monoclonal antibody that has chemotherapy attached to it. A monoclonal antibody isa molecule that is made to target a specific cancer cells and may affect normal cells.Chemotherapy is a type of cancer treatment that kills cells that grow and divide quickly. This caninclude cancer cells or normal cells. U3-1402 is designed to bring chemotherapy inside HER3-positive cancer cells and kill them. HER3 is one of a number of proteins that are thought to beelevated in breast cancer. A protein is a large molecule that is important for many of the processesthat happen in and around cells in the body. 
    You may be eligible for this research study if you have breast cancer and your cancer has grown after prior treatments. Along with that your tumor tissue tested should have showed your cancer to be HER3 positive.
    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02980341 STU00208625
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    Study Coordinator 1-855-NU-STUDY
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    (xIRB) SWOG 1701: A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
    The purpose of this study is to compare any good and bad effects of using ramucirumabalong with the usual chemo…
    The purpose of this study is to compare any good and bad effects of using ramucirumabalong with the usual chemotherapy combination (carboplatin and paclitaxel) to the usualchemotherapy combination alone. Ramucirumab is FDA-approved for non-small cell lungcancer but not for thymic cancer; however, ramucirumab in combination with carboplatin and paclitaxel is considered investigational and is not approved for this indication.Ramucirumab is a monoclonal antibody, a type of protein made in the laboratory that canbind to substances in the body, including cancer cells. Ramucirumab targets the vascularendothelial growth factor receptor 2 (VEGFR 2). VEGFR2 is an important molecule thatsupports the growth of blood vessels by a process called angiogenesis. Growth of theseblood vessels can feed tumors and cause them to grow. Ramucirumab blocks VEGFR2 andmay prevent angiogenesis in advance thymic tumor patients. This study will allow theresearchers to know whether this different approach is better, the same, or worse than theusual approach. To be better, the study approach should extend the amount of time youare cancer-free compared to the usual approach.This chemotherapy combination, carboplatin and paclitaxel, has already beenFDA-approved.
    You may be eligible if you have thymic cancer which is not ableto be treated with surgery. People who are not in a study are usually treated with radiationtherapy, hormone therapy or chemotherapy with FDA approved drugs such as doxorubicin,epirubicin, cisplatin, carboplatin, cyclophosphamide, ifosfamide, vincristine, etoposide,paclitaxel, and pemetrexed. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03694002 STU00209617
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    Study Coordinator 1-855-NU-STUDY
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    DRUG 2125-MEL-301 A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma
    The purpose of the study is to compare the effectiveness of IMO-2125 given in combination with ipilimumab compared to ipilimumab given alone. …
    The purpose of the study is to compare the effectiveness of IMO-2125 given in combination with ipilimumab compared to ipilimumab given alone. This is an investigational study, which means the study drug is experimental and is not approved by the U.S. Food and Drug Administration (FDA). Ipilimumab(Yervoy®) is a drug currently approved by the US Food and Drug Administration, Health Canada, the European Medicines Agency, and the Australian Therapeutic Goods Administration for the treatment of advanced melanoma. You will be randomly assigned by chance (like the flip of a coin) to receive either IMO-2125 + ipilimumab or ipilimumab alone. You have an equal chance of being put into any one of the groups. This means that you have a 1 in 2 chance of being on IMO-2125 + ipilimumab and a 1 in 2 chance of being on ipilimumabalone. The study treatment groups are: Group A: Ipilimumab and Group B:IMO-2125 + ipilimumab.  If you are assigned to GroupA, you will be given ipilimumab as an intravenous infusion (i.v., into a vein)over 90 minutes on weeks 1, 4, 7, and 10. You will receive study treatment for 10 weeks If you are assigned to GroupB, you will be given IMO-2125 as an intratumoral injection, which means it will be injected directly into a single tumor on weeks 1, 2, 3, 5, 8, 11, 16, 20 and 24. You will also be given ipilimumab as an i.v. over 90 minutes on weeks 2, 5,8 and 11. On days that you receive a combination of ipilimumab and IMO-2125,IMO-2125 will be given first. You will receive this study treatment for 24 weeks. 

    We are asking you to take part in this research study because you have refractory melanoma. 

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03445533 STU00209182
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    Study Coordinator 312 695 1102
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    NU DF18C03: A phase II study of atezolizumab in combination with pertuzumab plus high-dose trastuzumab for the treatment of central nervous system metastases in patients with Her2-positive breast cancer
    This research study is a Phase II clinicaltrial.  Phase II clinical trials test thesafety and…
    This research study is a Phase II clinicaltrial.  Phase II clinical trials test thesafety and effectiveness of an investigational intervention to learn whetherthe intervention works in treating a specific disease. In this research study, we are looking to seehow well your cancer responds to the combination of atezolizumab in combinationwith pertuzumab and trastuzumab. 

    Participants must be 18 years or older

    Participants must be diagnosed with HER2-postitive metastaticbreast cancer (MBC) that has spread to the brain

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03417544 STU00209101
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    Study Coordinator 1-855-NU-STUDY
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    DRUG PSMA-617: VISION: An International, Prospective, Open-Label, Multicenter, Randomized Phase 3 Study Of 177Lu-PSMA-617 In The Treatment Of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (MCRPC)

    The therapy we will be using in this study is called “radi…

    The therapy we will be using in this study is called “radionuclide therapy” and is an approach for the treatment of cancer that uses chemical compounds we sometimes refer to as “tumor-targeting agents” to deliver radiation directly to tumors to kill the tumor. The amount of radiation is selected in order to damage and destroy the tumor. The compound and the radiation reach tumor cells throughout the body by travelling through the bloodstream. The idea is that the compound which carries the radiation will target the tumor cells and not healthy normal tissue.

    Many cells contain a protein called prostate-specific membrane antigen (PSMA). There is a cancer called metastatic, castration resistant prostate cancer (mCRPC) that affects men and which often has the PSMA protein on the surface of cells of this cancer. The normal cells in the prostate do not normally express as much PSMA protein on their surface as do cancer cells.

    The compound that we are using in this study to seek and find the PSMA protein is called 177Lu-PSMA-617 (also called Lu-PSMA) and it is a radionuclide therapy. It delivers lutetium 177 (a radioactive metal) to cancers of the prostate which have PSMA proteins on the cell surface. Lu-PSMA is an experimental (investigational) radionuclide therapy, meaning that it has not been approved in the United States by the Food and Drug Administration (U.S. FDA) or any other regulatory authority, and it is not commercially available. It is too early to know whether treatment with Lu-PSMA will provide benefit to patients with prostate cancer, and the results of this study may help answer that question.

    The potential benefit from treatment with Lu-PSMA will be determined by comparing overall survival (how long patients live) in patients with progressive PSMA-positive mCRPC who receive Lu-PSMA in addition to best supportive/best standard-of-care to patients treated with best supportive/best standard-of-care alone.

    The study will also measure how well prostate cancer responds to Lu-PSMA, the safety of the treatment (by measuring the frequency and severity of side effects), whether pain improves or worsens, how long you live without your prostate cancer getting worse, and your quality of life.

    You may be eligible for this research study if you have been diagnosed with recurrent metastatic, castration-resistant prostate cancer.

    Morgans, AliciaMorgans, Alicia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03511664 STU00209123
    More Info

    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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    NU MTBC 18M02: Melanoma Tissue Bank Consortium Protocol

    The purpose of this research study is to create  a MTBC biorepository (the “MTBC Biobank”) ofhuman biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender…

    The purpose of this research study is to create  a MTBC biorepository (the “MTBC Biobank”) ofhuman biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history ofsun exposure (the “Annotating Data”).  This part of the project is called the “Biobanking Study”.  The second purpose is for MTBC to provide the Biospecimens and/or Annotating Data from the MTBC Biobank to researchers aroundthe world for them to use in specific studies in order to study melanoma (eacha “Future Use Study).   

    Melanoma is a lethal form of skin cancer and more research is necessary to helpscientists to understand what causes it, how to diagnosis it, how it can be prevented, and how it can be treated.  To do this research, scientists need biospecimens (like biopsied tissue and blood samples) from people who have been diagnosed with melanoma and other skin disorders. This study will help scientists learn about melanoma and the projectis being conducted on behalf of the Melanoma Tissue Bank Consortium(“MTBC”).   

     

    We are asking you to take part in this research study because you have melanoma or another skin disorder.Your participation is completely voluntary. You may choose not to take part.Your decision to sign this informed consent and authorization form in order to participate in the Biobanking Study and to allow the use of your Biospecimens and Annotating Data in a Future Use Study will not change the treatment you receive for your skin disorder. 

    Wayne, Jeffrey DWayne, Jeffrey D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00209847
    More Info

    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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