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Trials
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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NUGene: Gene-Disease Associations and Treatment Outcomes

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so import…

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to prevent and treat illnesses.

Want to make an impact in just 20 minutes? Give some blood, answer some questions, and share your health records with your study team’s database. Researchers use it to find disease patterns and search for new ways to prevent and treat illnesses.

Must be a patient at Northwestern or one of its affiliates.
Chisholm, Rex LChisholm, Rex L
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
STU00010003
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Study Coordinator 1 312 503 6200
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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 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 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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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 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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Jain, Ankit +1 312 503 9092
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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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Stockdale, Jazmine +1 312 694 2417
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NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in 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 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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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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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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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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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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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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Bagnowski, Katherine +1 312 503 3788
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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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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 research…
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).

Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
STU00202177
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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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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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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 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) 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. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
Some of the eligibility criteria include:

- Participants must have a recurrent, high or low risk non-muscle-invasive bladder carcinoma.
- Participants must (be BCG refractory) have received at least one 6-week course of BCG induction plus 1 maintenance dose, OR 2 full 6-week courses of induction BCG treatment.
- 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.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02808143 STU00202754
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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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NRG-GY006: A Randomized phase III 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 the effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, as 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 new 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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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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Bagnowski, Katherine +1 312 503 3788
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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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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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Study Coordinator 312 695 1102
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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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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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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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(xIRB NCI CIRB) SWOG 1602: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
The purpose of this study is to test two things:• Compare any …
The purpose of this study is to test two things:• Compare any good and bad effects of using the Tokyo-172 version of BCG with thecurrently used BCG LIVE (TICE® BCG) version of BCG on people with bladdercancer receiving BCG in the bladder. The study will be considered successful ifapproximately the same number of patients who receive the different treatments arefree from high grade recurrence of their bladder cancer after one year of treatment.• Using the Tokyo-172 version of BCG, compare any good and bad effects of adding aBCG vaccination (given under the skin) in addition to placing BCG in only thebladder. The study will be considered successful if the vaccination results in an 8%improvement in the number of patients who are free from high grade recurrence oftheir bladder cancer after one year of treatment.
Some of the eligibility criteria include: - Participants must have high grade bladder cancer thathas not entered the muscle - 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.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03091660 STU00205010
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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 moretreatment or additional post-operative chemotherapy), to any effects, goodand/or bad, of the experimental drug MK-3475 (also called pembrolizumab)after surgery. This study will allow the researchers to know whether treatmentwith MK-3475 (pembrolizumab) is better, the same, or worse than the usualapproach.

This study has two study groups (also called study “arms”). A computer willby chance assign you to one of the two study arms. This is calledrandomization. This is done by chance because no one knows if one studyarm is better, the same, or worse than the other arm. Once you are put on onearm, you cannot switch to the other arm. Neither you nor your doctor canchoose which arm you will be in.

 Some of the eligibility criteria include: Participants must be 18 years of age or older; Participants must have “triple-negative” breast cancer. This is the typeof breast cancer that doesn’t have receptors for estrogen, progesterone,or the protein HER2, that are found in some other types of breastcancer
Gradishar, William JGradishar, William J
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02954874 STU00205340
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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, t…

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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(xIRB NCI CIRB) ECOG-ACRIN 8143 A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Nivolumab is a drug that may help stimulate one’s immune system to attack any cancer cells that may rem…
Nivolumab is a drug that may help stimulate one’s immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent 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 kidney cancer that has been removed but is at risk for coming back. The study drug, nivolumab, is already FDA-approved for participants who have kidney cancer that has spread outside of the kidney to other organs or lymph nodes. The use of nivolumab in this study is investigational (not approved by the FDA) for early stages of cancer where we do not know for sure if the disease has spread outside of the kidney. 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 participants are able to live without any signs or symptoms of cancer compared to the usual approach.
  • Participants must have Renal Cell Cancer
  • Participants must be 18 or older
  • Participants must have disease confirmed by biopsy
Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03055013 STU00205209
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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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DRUG CA209-914: A Phase 3 Randomized Double Blind Study of Nivolumab Monotherapy or Nivolumab Combined with 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 stu…

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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(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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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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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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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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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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DRUG C-145-03 A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to find out if a drug named LN-…
The purpose of this study is to find out if a drug named LN-145 is safe and beneficial in the treatment of patients with recurrent and/or metastatic head and neck cancer when previous treatment has not worked. LN-145 is also called "tumor infiltrating lymphocytes" and is made up of specialized white blood cells called lymphocytes or "T-cells" grown from your tumor. These T cells were made by your body to attack your tumor. 
You are eligible to participate in this study because you have Squamous Cell Carcinoma of the Head and Neck cancer that has come back after treatment (recurrent) or has spread (metastatic) after the previous treatment. 
Villaflor, VictoriaVillaflor, Victoria
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03083873 STU00206171
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(xIRB) DRUG 201973: A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer
The purpose of this study is to evaluate the safety of the investiga…
The purpose of this study is to evaluate the safety of the investigational drug, GSK525762, and how well it works when taken with fulvestrant, a drug that is a standard treatment for estrogen receptor positive breast cancer. Researchers will test 2 dose levels of GSK525762 and fulvestrant. There will be 2 groups of subjects at each dose level. If dose level 1 is shown to be tolerated without serious side effects, a small number of consenting participants will be enrolled and start a second, higher dose level (dose level 2) of GSK252762. If DL1 is not safe, a lower dose will be given. If the small number of subjects completes DL2 and it is shown to be safe, additional subjects will be randomly assigned to receive either DL1 or DL2.
• Diagnosis of advanced or metastatic estrogen receptor-positive breast cancer (ER+BC) that hasn’t responded to previous endocrine treatment.
• Age of at least 18 years
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02964507 STU00206335
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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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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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(xIRB) Alliance A221505: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction
Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. Radiation treatments are given daily over a treatmen…
Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. Radiation treatments are given daily over a treatment course of 5 to 6 weeks. This study will examine whether a shorter course of radiation therapy (3 to 4 weeks) are safe and effective, will lower treatment costs, and improve patient satisfaction.This study has two study groups:  Group 1 will get the usual 5 to 6 weeks radiation therapy used for this type of cancer.  Group 2 will get a shortened course with 3 to 4 weeks radiation therapy for this type of cancer. Participants will be assessed during and after completing radiation, similar to usual care and the study doctor may recommend chemotherapy drugs or anti-estrogen medications that are commonly used before or after radiation therapy.
 Diagnosis with stage 2 or stage 3 breast cancer
 Age of at least 18 years
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03414970 STU00207162
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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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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.

Shah, AmiShah, Ami
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03147287 STU00207256
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Study Coordinator 1 312 695 1102
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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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Study Coordinator 312 695 1102
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(xIRB NCI) ECOG ACRIN 8153: Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel(also known as Jevtana®…
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel(also known as Jevtana®) with the usual approach of the hormonebased therapy abiraterone acetate (also known as Zytiga®) in combination with prednisone on patients with advanced prostate cancerthat have already undergone treatment with hormone therapy and the chemotherapydrug docetaxel.

· Participants must be 18 years or older

Participants have beendiagnosed with prostate cancer that has spread, and is able to grow even though drugsor other treatments to lower the amount of male sex hormones are being used tomanage the cancer.
VanderWeele, DavidVanderWeele, David
NCT03419234 STU00207949
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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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(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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(xIRB NCI) Alliance A031501: Phase III Randomized Adjuvant Study Of MK-3475 (pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carconima (AMBASSADOR) versus Observation

· · Had surgery to remove bladder cancer which is inthe deep muscle of the bladder wall (called mus…

· · Had surgery to remove bladder cancer which is inthe deep muscle of the bladder wall (called muscle-invasive bladder cancer) orurothelial cancer (in the urine collection area)

Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. Lurie Comprehensive Cancer Center ofNorthwestern University for complete screening information if you areinterested in this clinical trial.

The purpose of this study isto compare any good and bad effects of using a drug called MK-3475(pembrolizumab) after the removal of your muscle invasive bladder cancer orurothelial cancer. MK-3475 is a drug that uses a person’s own immune system totreat cancer. This study will allow researchers to know whether treatment withMK-3475 is better, the same, or worse than the usual approach. To be better,the MK-3475 should increase life by 9 months or more, compared to observationalone. The use of MK-3475 could prevent your cancer from returning but it couldalso cause side effects. This immunotherapy drug, MK-3475, is alreadyFDA-approved for use in other types of cancers, but for your type of cancer itis considered experimental. There will be about 739 people taking part in thisstudy.

VanderWeele, DavidVanderWeele, David
NCT03244384 STU00208176
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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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(xIRB) DRUG 017004: An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that …
JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that has not yet been approved for sale or use to the public by the United States Food and Drug Administration (FDA). This study is designed to test the safety and effectiveness of a new approach to treating Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This study has many parts and you will be asked to participate in one portion of the study. The Phase 1 portion of the study will evaluate whether the treatment works in treating your cancer. In the Phase 1 portion, you may be required to be on another cancer treatment called ibrutinib (IMBRUVICA®). Your study doctor will tell you which group you are eligible to be treated on. The Phase 2 is designed to assess JCAR017 as treatment versus standard of care. The approach involves modifying the patient's own immune cells, called T cells, to enable them to kill their cancer cells. T cells fight infections and can also kill cancer cells in some cases. In most cases, a patient's T cells are not able to kill their own cancer cells. In this study, some of the patient's T cells are removed from their blood, modified in a laboratory, and then given back to them by intravenous (IV) injection. While in the laboratory, researchers will put a new gene into the T cells that allows the patient's T cells to then recognize and kill the lymphoma cells. The method of putting the gene into the T cells uses a weakened virus that cannot multiply or spread. T cells that have genes added in the laboratory are called “genetically modified T cells” or “chimeric antigen receptor T cells (CAR T cells)”. When the genetically modified T cells recognize and attach to cancer cells, they have the ability to become activated and kill them. The modified T cells do not appear to recognize other normal cells in the body, with the exception of normal B cells. However, studies have shown that normal B cells will return after being treated with the modified T cells.
  • Participants must have any of the following types of lymphoma: Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
  • You must have received 2 or 3 prior treatments for your CLL or SLL
  • Participants must have cancer that has returned or has not responded to other treatment.
  • Participants must be 18 or older
Ma, ShuoMa, Shuo
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03331198 STU00208648
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Study Coordinator 312 695 1102
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Phase II Randomized Trial of Neo-Adjuvant Chemotherapy Followed by Surgery and Post-Operative Radiation Versus Surgery and Post-Operative Radiation for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)
The purpose of this research study is to compare any good…
The purpose of this research study is to compare any good and bad effects of using chemotherapy along with surgery and radiation therapy.  The addition of chemotherapy to the usual surgery and radiation could shrink your cancer/prevent it from returning.  
You can take part in this research study because you have cancer of the sinonasal area. 
Samant, SandeepSamant, Sandeep
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03493425 STU00208820
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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 found th…
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
NCT02750826 STU00208895
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Study Coordinator 312 695 1102
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(xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer
In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area an…
In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03488693 STU00208897
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Study Coordinator 1 312 695 1102
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ECOG-ACRIN 6174: STAMP: Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial

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 do…

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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Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A pilot Prospective Cohort Study

This study is being done to determine whether stellate ganglion block (SGB) with local anesthetic can reduce the number and severity of hot flashes in men with prostate c…

This study is being done to determine whether stellate ganglion block (SGB) with local anesthetic can reduce the number and severity of hot flashes in men with prostate cancer on ADT (Androgen Deprivation Therapy) who have hot flashes. You will be asked to come to Northwestern Medicine in downtown Chicago, IL for 2 visits over 6 months. During this time, you will keep a daily hot flash diary and complete weekly questionnaires. You will be given a parking pass and compensation for your participation. Please contact the study team to learn more.

Men with prostate cancer (with or without metastatic disease) on ADT (Androgen Deprivation Therapy) for at least 2 months

Experiencing bothersome and frequent hot flashes

Age 18 -70 years

Willingness to undergo an x-ray guided nerve block (stellate ganglion) with a local anesthetic drug

Walega, David RWalega, David R
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03796195 STU00208657
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Study Coordinator 312 695 0915
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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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Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors:Fit2ThriveMB

The Fit2ThriveMB study is designed to study the effectiveness of a 3 month technology-supported physical activity intervention in metastatic breast cancer patients. This program primarily focuse…

The Fit2ThriveMB study is designed to study the effectiveness of a 3 month technology-supported physical activity intervention in metastatic breast cancer patients. This program primarily focuses on increasing steps and is designed with progressions so that individuals of varying abilities will be able to engage in physical activity safely. All participants in the study will have access to a Fitbit and smartphone app specifically designed for this study, with half of participants obtaining immediate access and half obtaining access at a later time.

Females 18 years of age or older

Diagnosis of metastatic breast cancer

Fluent in spoken and written Englsh

Own a smartphone and have access to the internet

Engage in less than 150 minutes of moderate to vigorous physical activity

Phillips, SiobhanPhillips, Siobhan
STU00208930
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Hood, Susan
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NU MSK18U09: Metacure: Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
Prostate cancer feeds on testosterone, the male hormone. The purpose of this study is to test if treatment with medications that reduce the male hormone level in you…
Prostate cancer feeds on testosterone, the male hormone. The purpose of this study is to test if treatment with medications that reduce the male hormone level in your body for a few months before surgery can shrink the cancer as much as possible, which might reduce the chances of the cancer coming back in the future. These treatments include a hormone injection given monthly or every three months and the study drugs, which include abiraterone acetate, prednisone, and apalutamide. The injection and study drugs can also cause side effects. Radiotherapy will be recommended if there are high risk features when the doctors look at the prostate under the microscope after the surgery.

There are three cohorts inthis study that are based on the status of your cancer and the treatments youhave already received. For each cohort,the study drugs will be combined with other standard treatments for that typeof prostate cancer.

Some of the eligibility criteria include:

• Prostate cancer that has a high risk of coming back after surgery or radiotherapy by spreading to other parts of your body

• Age of at least 18 years

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.

Morgans, AliciaMorgans, Alicia
NCT03436654 STU00208899
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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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Erickson, Maia K 312 503 4347
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Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. H…

The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. Here, the antibody is obinutuzumab. It is looking for CD20, an antigen that is found on tumor cells. Two study drugs will be tested in this study: TGR-1202 and lenalidomide. Each of these study drugs may help the immune system fight cancer. During the study, you will get either obinutuzumab plus TGR-1202, obinutuzumab plus lenalidomide, or obinutuzumab plus the usual approach treatment for your cancer.

The addition of TGR-1202 or lenalidomide could shrink your cancer, 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. The antibody (obinutuzumab) and the regular chemotherapy approach are FDA-approved for use in follicular lymphoma, but they aren’t usually used together. The immune system drug, TGR-1202, is not FDA approved. The immune system drug lenalidomide is FDA approved, but not for follicular lymphoma.

Another purpose of this study is to test PET/CT scans, which are a way to take pictures of your type of cancer. The researchers want to use PET/CT scans to help diagnose and monitor your cancer. PET/CT scans are a part of regular care for your type of cancer. All of the patients taking part in this study will have PET/CT scans sent to a central PET/CT reviewer.

Another purpose of this study is to see whether a set of gene mutations (called m7-FLIPI) can predict whether your lymphoma will respond better or worse to the study treatment. Mutations are permanent changes in your DNA. The researchers will look for the mutations on your tumor tissue and in tumor cells found in your blood. All of the patients taking part in this study will have blood and tissue submitted for these gene mutation tests.

You may be eligible for this research study if you have follicular lymphoma that has either not responded to previous treatment or that has come back after previous treatment.

Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03269669 STU00209296
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Study Coordinator 312 695 1102
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NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast
The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. …
The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause harmful effects to other organs. When tamoxifen is taken by mouth, it is broken down by the liver into two main active forms, one of which is 4-hydroxytamoxifen, also called 4-OHT. Tamoxifen is approved by the Food and Drug Administration (FDA) while 4-OHT is not and is, therefore, considered investigational. However, 4-OHT has anti-cancer activity, and has been developed as a quick drying medicated gel that can be applied to the breast skin. Early results from two previous studies show that 4-OHT gel, when applied to the skin, gets into the breast and blocks breast cancer cell growth as effectively as oral tamoxifen. Unlike oral tamoxifen, the gel is concentrated in the breasts and therefore very little tamoxifen reaches the blood or other parts of the body. Also, some women lack the proteins that are responsible for the break-down of tamoxifen. It is possible that the use of 4-OHT gel will be more effective than oral tamoxifen in these women.
Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiation
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 250 E. Superior St.
    Chicago, IL
NCT04009044 STU00208708
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Pulliam, Natalie +1 312 472 4767
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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
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    Chicago, IL
NCT03698019 STU00209408
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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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(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
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NCT03694002 STU00209617
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(xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

The purpose of this study is to compare any good and bad effects of using proton therapy to using photon

therapy. Photon…

The purpose of this study is to compare any good and bad effects of using proton therapy to using photon

therapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam of

proton particles to send radiation inside the body to the tumor. This study will allow the researchers to know

whether proton therapy is better, the same, or worse than the usual approach. Proton therapy may have less

negative effects on brain function than photons because less brain is exposed to radiation when proton therapy

is used. However, proton therapy might also be associated with more frequent tumor recurrences.

-Participants must be 18 years of age or older

-Participants must be diagnosed with a brain tumor

Kruser, TimothyKruser, Timothy
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    Chicago, IL
NCT03180502 STU00209631
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312 695 1102
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A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mut…

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies.

  • Participants must be18 years or older
  • Participants must bediagnosed with non-small cell lung cancer
Chae, Young KwangChae, Young Kwang
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03851445 STU00209659
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(xIRB NCI CIRB) ECOG-ACRIN 2174: A Phase II/III Study of Peri-operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Immunotherapy with antibodies, suchas nivolumab and ipilimumab, may remove the brake on the body's immune systemand…

Immunotherapy with antibodies, suchas nivolumab and ipilimumab, may remove the brake on the body's immune systemand may interfere with the ability of tumor cells to grow and spread. Theaddition of nivolumab before surgery could help shrink the cancer more beforesurgery. The addition of nivolumab along or in combination with ipilimumab toafter surgery could prevent it from returning.

This phase II/III trial studies theusefulness of treatment with drugs nivolumab and ipilimumab in addition tostandard of care chemotherapy and radiation therapy in patients with esophagealand gastroesophageal junction adenocarcinoma who are undergoing surgery. Thereare two main purposes to this study. One purpose is to compare the usualpre-surgery treatment alone to using nivolumab plus the usual treatment.Another purpose is to compare post-surgery treatment with nivolumab alone tousing nivolumab plus ipilimumab.

Patients who are of 18 years of ageor older may be able to take part in this study if they have locoregionalesophageal or gastroesophageal junction (GEJ) adenocarcinoma.

Mulcahy, Mary FrancesMulcahy, Mary Frances
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    Chicago, IL
NCT03604991 STU00209746
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DRUG FOR46-001 - A Phase 1 Study of FOR46 Administered Every 21 Days in Patients with Metastatic Castration-Resistant Prostate Cancer (MCRPC)

The purpose of this study is to learn more about an experimental drug called FOR46 for Injection (also called “FOR46” or “study drug” in this consen…

The purpose of this study is to learn more about an experimental drug called FOR46 for Injection (also called “FOR46” or “study drug” in this consent form). FOR46 is an investigational medication, which means that it has not been approved by the FDA to be sold to the public.

FOR46 is being developed to see if it can treat metastatic prostate cancer. FOR46 is made up of an antibody (a type of protein) and an anticancer drug and is given intravenously (IV) (by vein). FOR46 is designed to travel through the bloodstream throughout the body and find cancer cells, and ultimately kill them or delay cancer growth.

During this study, the safety and anticancer activity of FOR46 will be evaluated, including looking for the highest dose level of FOR46 that can be taken safely. It is not known if there is a benefit to using FOR46 to treat metastatic prostate cancer in humans. In animal studies, FOR46 was found to be tolerated and able to kill prostate cancer cells and/or delay the growth of these cells. However, FOR46 has not yet been given to humans.

Males at least 18 years old who have metastatic prostate cancer.

VanderWeele, DavidVanderWeele, David
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03575819 STU00209324
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DRUG AML003: Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (devimistat) in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥ 50 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML)

· · To see if CPI-613 (devimistat)influences the duration of AML-free period for any patients that get betterafter receiving the combination of CPI-613 (devimistat) plus Cytarabine andMitoxantrone.

The length of the study will be upto 18 weeks (~ 4 months) and patients may receive Maintenance cycles (eachcycle is 4 weeks) until bone marrow transplantation, the patient’s AML worsensor until the end of study, after which patients will be followed for up to 12months to collect important information about their health.

Patientswho are of 60 years of age or older may be able to take part in this study ifthey have AML that has either been resistant to previous therapies or if theyhave relapsed after achieving remission with a prior therapy.

Frankfurt, OlgaFrankfurt, Olga
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    Chicago, IL
NCT03504410 STU00209526
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A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a com…

The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a combination treatment of ibrutinib and obinutuzumab plus the study drug, venetoclax. The addition of venetoclax to the usual treatment may or may not help shrink your cancer. But, it could also cause side effects, which are described in the risks section below. This study will also compare the usual treatment of indefinite ibrutinib therapy to a time limited therapy schedule of approximately 18 months to better understand their effects on your quality of life and the costs of your care.

This study will help the study doctors find out if these different approaches are equally effective to the usual approaches while requiring a shorter duration of treatment. To decide if they are better, the study doctors will be looking to see if the study drugs do no worse in terms of time to progression and overall survival compared to the usual approach, even though they require a shorter duration of treatment. Ibrutinib, obinutuzumab, and venetoclax are all FDA approved drugs to treat CLL, but they will be considered investigational in the setting of this trial. There will be about 720 people taking part in this study.

  • Participants must be 18 years or olderand < 70
  • Participants must bediagnosed with Chronic Lymphocytic Leukemia (CLL), a type of bloodcancer.
Ma, ShuoMa, Shuo
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    Chicago, IL
NCT03701282 STU00209948
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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”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, hi…

The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun 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 around the world for them to use in specific studies in order to study melanoma (“Future Use Study).

Melanoma is a lethal form of skin cancer and more research is necessary to help scientists to understand what causes it, how to diagnose 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 projects 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
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STU00209847
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NU 18U10: A Phase II Study of sEphB4-HSA in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The purpose of this study is to test whether the study drug sEphB4-HSA (a form of protein), will treat your prostate cancer that has come back or is not responding to previous treatments. The study …

The purpose of this study is to test whether the study drug sEphB4-HSA (a form of protein), will treat your prostate cancer that has come back or is not responding to previous treatments. The study drug is considered an experimental drug because it has not been approved for sale by the United States Food and Drug Administration (FDA).

The study drug prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.

Some of the eligibility criteria include:

• Diagnosis of metastatic castration-resistant prostate cancer

• Age of at least 18 years

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.

Hussain, MahaHussain, Maha
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    Chicago, IL
NCT04033432 STU00209511
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(xIRB) DRUG 017006: A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients with Aggressive B-cell NHL (017006)
This study is designed to evaluate the safetyand effectiveness of a new approach to treat adults diagnosed with NHL, whohave had their cancer come bac…
This study is designed to evaluate the safetyand effectiveness of a new approach to treat adults diagnosed with NHL, whohave had their cancer come back or didn’t respond to one previous line oftherapy and are not eligible to receive a stem cell transplant. This studytreatment is called JCAR017. JCAR017 (study treatment) is an investigationaltreatment. Investigational means that it is an experimental therapy that hasnot yet been approved for sale or use to the public by the United States Foodand Drug Administration (FDA).
  • Participantsmust have a confirmed diagnosis of aggressive B-cell Non-Hodgkin Lymphoma (NHL)and have received a single previous line of therapy.

Note: This is only a partial list of eligibility criteria. Pleasecontact the Robert H. Lurie Comprehensive Cancer Center of NorthwesternUniversity for complete screening information if you are interested in thisclinical trial.
Gordon, Leo I IGordon, Leo I I
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    Chicago, IL
NCT03483103 STU00210077
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Study Coordinator 312 695 1102
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A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to answer the following questions:

  • Is adding a new anti-cancer …
  • This study is being done to answer the following questions:

  • Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) better, the same as, or worse than the usual treatment alone for untreated older patients with CLL?
  • Can patients who have no detectable CLL after a year of receiving the usual treatment plus the new anti-cancer drug discontinue therapy?
  • We are doing this study because we want to find out if thisapproach is better or worse than the usual approach for your chroniclymphocytic leukemia. The usual approachis defined as care most people get for chronic lymphocytic leukemia.

    • Participants must be 70 years orolder
    • Participants must be diagnosed with Chronic LymphocyticLeukemia (CLL), a type of blood cancer.
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210099
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    Study Coordinator 312 695 1102
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    DRUG FF21101US101: A Phase 1 Dose-escalation Study of Radio-labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer

    The goal of this clinical research study is to learn the highest tolerable dose of the study drug, FF-21101(90Y), that can be given to patients with advanced cancer and …

    The goal of this clinical research study is to learn the highest tolerable dose of the study drug, FF-21101(90Y), that can be given to patients with advanced cancer and to study the safety of the drug. Researchers think that large amounts of a protein called P-cadherin may make your tumor more responsive to the study drug.

    All adults patients with advanced cancers are eligible to participate. 
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT02454010 STU00209749
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    Study Coordinator 312 695 1102
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    DRUG KRT-232-103: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

    We are asking you to take part in this research study because you have been diagnosed with Merkel cell carcinoma (MCC) and your prior treatment with a specific immunotherapy (a type of therapy called anti-PD-1 or anti-PD-L1) was not or is no longer effective for your disease. The purpose of this study is to evaluate how well tolerated KRT-232 is when given to participants with Merkel cell carcinoma, and whether KRT-232 can improve your MCC.

    In order to participate in this study, your Merkel cell carcinoma cells must be a certain type of cell, called “p53 wild type” cells (p53wt).
    Chandra, SunandanaChandra, Sunandana
    NCT03787602 STU00209401
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    Study Coordinator 312 695 1102
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    DRUG CD07_TNBC: A Phase Ib/II Study of Leronlimab (PRO 140) Combined with Carboplatin in Patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC)
    The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carbopl…
    The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carboplatin, is safe and effective for the treatmentof patients with metastatic Triple Negative Breast Cancer (mTNBC).

    You may be eligible to take part in this research study if you have Triple Negative Breast Cancer that has come back, i.e. spread to other areas of your body (metastatic), after you have previously received chemotherapies at the time when your cancer was first detected.

    Cristofanilli, MassimoCristofanilli, Massimo
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      Chicago, IL
    NCT03838367 STU00209594
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    Study Coordinator 312 695 1102
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    Alliance A041703: A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-negative CD22-positive B-lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease

    Thepurpose of this study is to test the good and bad effects of th…

    Thepurpose of this study is to test the good and bad effects of the combination ofdrugs called inotuzumab ozogamicin and blinatumomab. The study doctors hope tolearn if the combination of study drugs will cause cancer to go away andprevent leukemia from coming back.

    Inotuzumabozogamicin and blinatumomab have already been approved by the FDA to treatrelapsed or refractory ALL as well as other cancers. The combination ofinotuzumab ozogamicin and blinatumomab is considered investigational for thisstudy.

    Participantswith ‘untreated ALL’ or ‘relapsed or refractory ALL’, will get a combination ofdrugs called inotuzumab ozogamicin and blinatumomab. This combination of drugsis known to be effective in patients with relapsed or refractory leukemia, butit is not the usual chemotherapy for patients with ‘untreated ALL.’Participants will also get a drug called methotrexate to prevent cancer cellsfrom entering the central nervous system.

    Diagnosed with Acute Lymphoblastic Leukemia (ALL) that is untreated or has come back. Participants with untreated ALL must be 60 years of age or older. Participants with ALL that has relapsed or come back must be at least 18 years of age or older. 
    Dinner, ShiraDinner, Shira
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      Chicago, IL
    NCT03739814 STU00210163
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    Study Coordinator 312 695 1102
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    A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug…
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after a year of receiving the usual treatmentplus the new anti-cancer drug discontinue therapy? 
    Some of the eligibility criteria include: - Participants must have intermediate or high-risk chronic lymphocyticleukemia that has not been treated before - 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.
    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210225
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    Study Coordinator 312 695 1102
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    Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of HCC

    In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver res…

    In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.

    Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).

    Liver resection is used to remove the part of the liver that has the liver tumor(s). It has been shown that Y90 radioembolization can increase the untreated liver’s size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.

    The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.

    If you participate in this study, you will have standard-of-care Y90 radioembolization as well as study-specific imaging and two optional liver biopsies. You will participate in the study for up to 3 months. Your health status will continue to be followed for up to 5 years.

    Patients enrolled in the study will receive up to $195.00 for their participation.

    You are eligible to participate in this study if:

    1. You are an adult 18 years of age or older

    2. You have been diagnosed with hepatocellular cancer and may be a liver resection candidate to remove your disease

    Lewandowski, Robert JLewandowski, Robert J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04390724 STU00209629
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    Kennedy, Kristie +1 312 695 4023
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    NU G18M02: Phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma

    This is a phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma.The pur…

    This is a phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma.The purpose of this study is to compare relapse-free survival (RFS) rate at 3 years of patients with locally treated high-risk ocular melanoma treated with adjuvant nivolumab/ipilimumab combination versus a matched control population. We are asking you to take part in this research study because you have high-risk ocular melanoma.This type of cancer is typically treated with surgery to remove the eye (enucleation) or radiation to the eye (radioactive plaque therapy).

    You may be eligible if you have high risk of ocular melanoma. 
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03528408 STU00209653
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination with Standard of Care Chemotherapy and Durvalumab in Combination with Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer
    The reason for the study is to find a more effective treatment for advanced urothelialbladder cancer. AstraZeneca is doing this research to find out if the medication calledDurvalumab and Tremelimumab when combined with standard of care (SoC)chemotherapy treatment will work and be safe for the treatment of advanced urothelialbladder cancer. Durvalumab as monotherapy has been approved by the FDA as therapyfor the treatment of locally advanced or metastatic urothelial carcinoma, for patient whose cancers progressed during or after platinum-based chemotherapy. Durvalumab asmonotherapy has also been approved by the FDA and the European Medicines Agency(EMA) for the treatment of patients with locally advanced non-small cell lung cancer afterchemoradiation therapy. Durvalumab, when given in combination with chemotherapy andTremelimumab, is still in the development stage for the treatment of advanced urothelialbladder cancer, and this combination is not approved for treatment of urothelial bladdercancer, except for use in research studies like this. You will also receive chemotherapyon this study, regardless of which treatment arm you are in. This chemotherapy consistsof gemcitabine and cisplatin or carboplatin, which are standard of care treatments givenin to patients with advanced bladder cancer. 
    Some of the eligibility criteria include: - Participants must have advanced urothelial bladder cancer - 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.
    VanderWeele, DavidVanderWeele, David
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03682068 STU00209828
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    Study Coordinator 312 695 1102
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    NU UNC19I02: A single arm, multi-center Phase 2 trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas

    The study drug, avelumab, is an investigational drug that allows the immune system to attack and kill cancer cells. This resea…

    The study drug, avelumab, is an investigational drug that allows the immune system to attack and kill cancer cells. This research study will investigate whether adding avelumab earlier to the usual treatment will be better than receiving only the usual treatment.

    You may be eligible for this research study if you have gastric or esophageal cancer that is either unresectable (cannot be taken out by surgery) or has spread to other areas of your body (advanced or metastatic). Also, your cancer has a change in the gene called the human epidermal growth factor receptor type 2 (HER2) which causes an overexpression of this gene.
    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03783936 STU00210014
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    Study Coordinator 312 695 1102
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    A Phase II, Open-Label, Multicenter, Randomized Study Of The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab In Patients With Previously Untreated Advanced Melanoma
    The purpose of this study is to compare the effects, good or bad, of PCV plus pembrolizumab vers…
    The purpose of this study is to compare the effects, good or bad, of PCV plus pembrolizumab versus pembrolizumab alone on patients with melanoma. In this study, particpants will get either PCV plus pembrolizumab or pembrolizumab alone.The goal of a PCV is to help train the immune system to recognize and attack cancer cells. And because the immune system has memory, it is hoped that once the immune cells have been trained, they will continue to work long after the vaccine is given. This treatment is a type of immunotherapy. To make PCV, samples of tumor tissue and blood will be collected and tested to see if a vaccine can be made for participants.Pembrolizumab is approved in the United States and the European Union, as well as other countries, for the treatment of unresectable or metastatic melanoma, and several other indications.PCV is an experimental drug, which means health authorities have not approved PCV in combination with pembrolizumab for the treatment of melanoma, and it has not been tested in people with untreated melanoma prior to this study.
    Participants must be age 18 years or older. Metastatic or unresectable locally advanced melanoma. 
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03815058 STU00209868
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    Study Coordinator 312 695 1102
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    (xIRB) ETCTN 10009: A Phase 1b Study of the Anti-PD1 Antibody Pembrolizumab in Combination with the Histone Deacetylase Inhibitor, Entinostat for Treatment of Patients with Myelodysplastic Syndromes After DNA Methyltransferase Inhibitor Therapy Failure

    Participants who have myelodysplasticsyndrome…

    Participants who have myelodysplasticsyndrome (MDS) or acute myeloid leukemia (AML) that arose from prior MDS andhave already been treated with azacitidine (Vidaza) or decitabine (Dacogen)will be enrolled into this study.

    This study uses a combinationof two drugs: Pembrolizumab which has already been FDA-approved for othercancers but not for MDS or AML and is given by vein. The other drug entinostatis a pill given by mouth and has been tested in some cancers, including MDS andAML, but is not approved for any cancer.

    The purpose of this study isto test whether giving entinostat by mouth along with the other drugpembrolizumab by vein is a safe combination and whether it could help your MDSor AML.

    All the study participants will get the same studydrugs, entinostat in combination pembrolizumab, in either the part 1 or part 2study groups.

    Part1 Dose Escalation Group: Different doses of the study drug entinostat will begiven with a fixed dose of pembrolizumab. The first 3 to 6 study participants received entinostat on day 1 and day8 of each cycle. The next 3 to 6 studyparticipants will receive entinostat only on day 1 of each cycle. If this dosedoes not cause serious side effects, this dose will be used in the next part ofthe study (Dose expansion group-see below).

    Part2 Dose Expansion Group: Once we determine the dose schedule of entinostat incombination with pembrolizumab that is considered safe to be given on thisstudy, we will then recruit 15 more patients at that dose schedule.

    Pathologically confirmed MDS diagnosis or AML

    Ages 18 years or older

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02936752 STU00210588
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    Study Coordinator 312 695 1102
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    A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors
    Research study which involves the use of a combination of an Enriche…
    Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
    Leventhal, Joseph RLeventhal, Joseph R
    NCT03995901 STU00209928
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    Stare, Dianne 312 694 0240
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    DRUG DCC-2036-01-003: An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors
    This study will evaluate the safety and tolerability of rebastinib when …
    This study will evaluate the safety and tolerability of rebastinib when taken in combination with the anti-cancer chemotherapy paclitaxel (also known as Taxol or Onxal). 
    You may be eligible to take part in this research study if you have been diagnosed withtriple-negative breast cancer, inflammatory breast cancer, ovarian cancer or endometrial cancer.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03601897 STU00210178
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    Study Coordinator 312 695 1102
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    NU UP19B05: Pragmatic Phase III Randomized Trial Of Proton vs. Photon Therapy For Patients With Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
    This study is being conducted to compare two types of standard care…
    This study is being conducted to compare two types of standard care radiation therapy: PHOTON THERAPY (pronouced “fotahn”) and PROTON THERAPY (pronouced “pro-tahn”).
    Patients may be eligible for this study if they have been diagnosed with non-metastatic breast cancer (meaning the cancer has not spread to other organs) and will be having radiation therapy
    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00210737
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    1-855-NU-STUDY
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    DRUG AL3818-US-004: A Phase III Study of AL3818 (Catequentinib, Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

    If you have ASPS, the main purpose of the study is to learn if you respond to treatment with …

    If you have ASPS, the main purpose of the study is to learn if you respond to treatment with a drug called AL3818. If you have either LMS or SS, the main purpose is to learn if AL3818 delays the time until your cancer worsens when compared to another drug called dacarbazine.

    You may be eligible for this research study if you have a soft tissue sarcoma (STS) - specifically alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), or synovial sarcoma (SS) - and you either need new treatment or your prior treatments have not been effective.
    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016819 STU00210420
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    Study Coordinator 312 695 1102
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    Effect Of Centering Pre-operative Counseling On Patient Reported Anxiety
    Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of i…
    Comprehensive pre-operative counseling and education has been shown to play an important role in quality of life, anxiety and depression among cancer patients. Traditionally, patients are counseled in the office at the time of informed surgical consent. However, there are several problems to this model including patient anxiety, confusion, information overload, and time constraints that may lead to sub-optimal counseling. Additionally, multiple studies have reported that patients forget half of what they have been told within 5 minutes of a health consultation and remember only 20% of the information passed on to them. Centering patient counseling has been used in other fields of medicine and has been shown to improve outcome in Obstetrics, Psychiatry, Gastroenterology, and Medical Oncology. The rationale behind centering care is that providers can spend more time counseling and educating a larger audience at once, and it allows the whole group to benefit from individual questions, concerns, and complaints. Additionally, it establishes a network for patients to connect with other women going through similar stressful events.

    The primary objective of the study is to evaluate the effect of pre-operative counseling in a group setting on patient reported anxiety for patients scheduled to undergo surgery for a known or suspected gynecologic malignancy. Patient reported anxiety will be evaluated using a validated Patient-Reported Outcomes Measurement Information System (PROMIS) survey. We hypothesize that the group counseling session will reduce patient reported anxiety by a clinical meaningful level. Secondary objectives will evaluate the effect of the intervention on patient reported depression levels and compare adherence to Enhanced Recovery After Surgery (ERAS) instructions, utilization of unscheduled health care resources, and anxiety/depression levels to historical controls.

    Any patient who is scheduled to undergo major surgery for a gynecologic cancer.
    Barber, EmmaBarber, Emma
    • Map it 250 E. Superior St. Fourth Floor
      Chicago, IL
    NCT04068675 STU00209941
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    Gwynn, Katherine +1 312 472 5726
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    (XIRB) DRUG CPI-006-001: A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent or In Combination With Ciforadenant, with Pembrolizumab, And With Ciforadenant Plus Pembrolizumab In Adult Subjects With Advanced Cancers
    The purpose of this research is to…
    The purpose of this research is to evaluate the safety of the study drug called CPI-006 when administered alone, or in combination with another drug called Ciforadenant, or in combination with another drug called Pembrolizumab, or when given with Ciforadenant plus Pembrolizumab.
    All adults subjects 18 years of age or over with advanced or metastatic cancer that has grown, spread, and/or has not responded to previous treatments are eligible to participate.
    Sosman, JeffreySosman, Jeffrey
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03454451 STU00210900
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

    The purpose of this study is to compare nivolumab plus the three chemotherapy drugs: doxorubic…

    The purpose of this study is to compare nivolumab plus the three chemotherapy drugs: doxorubicin, dacarbazine, and vinblastine sulfate (AVD) to brentuximab vedotin plus the three chemotherapy drugs: doxorubicin, dacarbazine, and vinblastine sulfate (AVD), followed by targeted radiation therapy in some patients with lymphoma that does not completely respond to therapy. The addition of either nivolumab or brentuximab vedotin to the usual treatment could shrink the cancer or extend your time without your disease symptoms coming back.

    Nivolumab is an immunotherapy drug (a type of drug that works by boosting your immune system) that attaches to a target protein called PD-1 (found within white blood cells) and helps to increase the immune system’s activity against the cancer. Brentuximab vedotin is an antibody drug conjugate, which means that the drug contains an antibody that attaches to a protein (CD30) that is found on the surface of classical Hodgkin Lymphoma cells and then releases a drug inside those cells that kills the cancer cells.

    This study will help the study doctors find out if one of the drug combinations (nivolumab plus the usual chemotherapy or brentuximab vedotin plus the usual chemotherapy) is better, the same, or worse than the other drug combination, followed by radiation therapy in some patients. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 2 years or more after the completion of the study treatment and which drug combination extends the overall survival of patients at 10 years after completion of the study treatment.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis newlydiagnosed and previously untreated stage III or IV classical Hodgkin lymphoma
    Winter, Jane NormaWinter, Jane Norma
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03907488 STU00210926
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB: ECOG-ACRIN Z171: Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women

    This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will re…

    This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will result in less nerve damage (known as peripheral neuropathy)in African-American women.

    You may beeligible to participate in this study if you are an adult with breast cancerand if you self-identify as black, African American, or of African descent.

    Shah, AmiShah, Ami
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04001829 STU00210984
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    Study Coordinator 312 695 1102
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    (xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating p…
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of multiple myeloma
    • Participants 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.
    Singhal, SeemaSinghal, Seema
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04133636 STU00210994
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10107: Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma

    Phase 2:

    Participants withmalignant pleural mes…

    Phase 2:

    Participants withmalignant pleural mesothelioma which has grown or has returned after initialtreatment with chemotherapies, and tumor tissue that shows the expression of theprotein mesothelin to a certain degree will be enrolled into Phase 2 of thestudy.

    The purpose of Phase 2is to compare the effects, good and/or bad, of anetumab ravtansine when givenin combination with pembrolizumab to the use of pembrolizumab alone in patientshaving moderate or high levels of a protein called mesothelin in the tumorsample.

    This study will allow researchers to know whether this different approach is better, the same orworse than treatment with MK-3475 (pembrolizumab) alone. Another purpose ofthis study is for researchers to learn whether biomarker tests can help predictwhich patients may respond well to the study drugs. Anetumab ravtansine has notbeen approved by the FDA and is considered experimental.

    Group 1 will receiveMK-3475 (pembrolizumab), and Group 2 will receive anetumab ravtansine andMK-3475 (pembrolizumab).

    All participants willreceive the study drug(s) for up to a maximum of two years. After they finishtreatment with (MK-3475) pembrolizumab and anetumab ravtansine or pembrolizumabonly, their doctor will follow their condition every three months by telephonefor up to one year.

    participants 18 years or older who have malignant pleural mesothelioma which has grown or hasreturned after initial treatment with chemotherapies, and tumor tissue thatshows the expression of the protein mesothelin to a certain degree
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03126630 STU00211023
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG 18-0402: A Phase 1A/B Dose-Escalation Study Followed by Expansion Cohorts of NGM120, A GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, In Subjects With Advanced Solid Tumors And Pancreatic Cancer Using Combination Therapy
    find out what effects, both good and/or bad, ofthe s…
    find out what effects, both good and/or bad, ofthe study drug “NGM120”, as well as the combination of NGM120 and standardtherapy (gemcitabine and Abraxane) may have on you and your type of cancer andyour cancer associated loss of appetite, weight loss and loss of muscle.

    • Participants must be 18 years or older

    •Participants must have a confirmed diagnosis of advanced solid cancers

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04068896 STU00211037
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

    The purpose of this study is to compare the treatment of carbopl…

    The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy toletrozole alone. The use of the hormonal therapy drug, letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

    This study will investigate if this approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for patients with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of patients in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone.The study doctors will be looking to see if the letrozole alone prolongs the time cancer is in remission, or the duration of time participants are alive after treatment.

    Letrozole is approved by the FDAfor breast cancer, but is not FDA approved for ovarian cancer and considered experimental in this setting.

    Participants will get either the combination of paclitaxel and carboplatin for four and a half months followedby letrozole or letrozole alone, as long as they are tolerating the letrozoledrug (i.e., have not developed any allergies or severe side effects with themedication) and have not experienced a recurrence or progression of their disease.

    After participants finish their study treatment, their doctor and study team will continue to follow theircondition and watch for side effects during clinic visits or by phone. Participants will be checked every 3 months for the first 3 years aftertreatment. After that, this will happen every 6 months for two years.

    • Diagnosis of low-grade serous carcinoma of the ovary or peritoneum.
    • At least 18 years old.
    Barber, EmmaBarber, Emma
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04095364 STU00211055
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    Study Coordinator 312 695 1102
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    (xIRB) Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

    This study is being done to answer the following question:

    Can we lower the chanc…

    This study is being done to answer the following question:

    Can we lower the chance of your prostate cancer growing or spreading by adding either prostate removal surgery or radiation therapy to the usual combination of drugs?

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

    The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST), which is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT) with or without the use of chemotherapy. ADT is an antihormone therapy whose main use is in treating prostate cancer. The combination of SST and surgery or radiation therapy is considered experimental.

    Participants must be 18 years or older

    Participants must have a confirmed diagnosis of metastatic prostate cancer

    VanderWeele, DavidVanderWeele, David
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03678025 STU00211063
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

    The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks…

    The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks with cisplatin chemotherapy to a reduced-dose radiationgiven over either 6 weeks with cisplatin or 5 weeks with the immunotherapydrug, nivolumab. A lower dose of radiation as compared to the usual radiationtreatment dose could be as effective in lengthening the time without the cancergetting worse.

    This study will helpresearchers find out if this different approach is the same or worse than theusual approach. To decide if it is the same, the study doctors will be lookingto see if the study approach maintains the length of time without cancergetting worse compared to the usual approach. If the study approach is the sameas the usual approach, the study will advance to the second part, the phaseIII, and participants may be asked to participate in the second part of thestudy.

    The purpose of thesecond part of this study is to compare the usual treatment of a standard-doseradiation given over 6 weeks with cisplatin chemotherapy to a reduced-doseradiation given over either 6 weeks with cisplatin or 5 weeks with theimmunotherapy drug, nivolumab. A lower dose of radiation as compared to theusual radiation treatment dose may or may not be as effective in lengtheningthe time without the cancer getting worse. Another purpose of the second partof this study is to see if a lower dose of radiation as compared to the usualradiation treatment dose could also have a better effect on a participant'swell-being.

    We are asking you to take part in this research study because you have low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. 
    Gentile, MichelleGentile, Michelle
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03952585 STU00211079
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    Study Coordinator 312 695 1102
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    DRUG M16-438: A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-Tumor Activity of ABBV-321 in Subjects with Advanced Solid Tumors Associated with Overexpression of the Epidermal Growth Factor Receptor (EGFR)
    The purpose of this study is to find out whether the study drug, ABBV-321, is…
    The purpose of this study is to find out whether the study drug, ABBV-321, is safe to use in patients with advanced solid tumors and glioblastoma multiform (GBM).
    All subjects 18 and above with advanced lung and brain cancers are eligible to participate
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03234712 STU00209932
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG KRT-232-104: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML)

    Thisstudy will test an investigational drug called KRT-232 that has not be…

    Thisstudy will test an investigational drug called KRT-232 that has not beenapproved for the potential treatment of AML. This study will determine if thisdrug is able to reduce the growth of unhealthy or tumor cells, and help restorethe function of your bone marrow. The study drug will be given along withanother therapy for AML assigned by the study doctor. This other therapy will be either cytarabine(injected under the skin) or decitabine (injected into a vein).

    Thereare 2 parts planned for this study, Part A (Phase 1b) will test different dosesof KRT-232 given with either cytarabine or decitabine to identify therecommended dose for Part B. Part B (Phase 2) will continue to test thisKRT-232 recommended dose with either cytarabine or decitabine to determine ifit is a tolerable and effective treatment for AML.

    Participantsat our site will currently participate in only Part A.

    Participantswill take the study drug until their cancer becomes worse, have severe sideeffects, or the research study ends.

    • Participants must have been diagnosed with Acute Myeloid Leukemia (AML)
    • Participants must be 18 years of age or older
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04113616 STU00211193
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB NRG LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

    Thepurpose of this study is to compare the usual treatment to atezolizumab plusthe usual treatment. This study will help the study do…

    Thepurpose of this study is to compare the usual treatment to atezolizumab plusthe usual treatment. This study will help the study doctors find out if thisdifferent approach is better, the same or worse than the usual approach. To decide if it is better, the study doctorswill be looking to see if the study drug increases the average lifespan ofpatients by 6 months or more compared to the usual approach.

    Thisimmunotherapy drug, atezolizumab, is approved by the FDA for use in metastaticnon-small cell lung cancer for patients whose cancer progresses. But, it is notapproved for use in small cell lung cancer.

    Thisstudy has 2 study groups. Allparticipants will have received one cycle of chemotherapy before entering thestudy. On the study all participants will receive 3 cycles of chemotherapy (fora total of 4 cycles including the one cycle of chemotherapy received beforeentering the entry), plus radiation.

    • Group 1

    Participants in group 1will get the usual chemotherapy used to treat this type of cancer (etoposideand either cisplatin or carboplatin) 3 weeks for 3 cycles; each cycle equals 21days. In addition, you will receive the usual radiation to your tumor.Radiation will be given either twice a day for approximately 3 weeks or once aday for approximately 6-7 weeks.

    • Group 2

    Participants in group 2will get the same chemotherapy and radiation as noted above, plus the studydrug called atezolizumab. The atezolizumab will be given on days 1 or 2 of eachchemotherapy cycle and will continue every 3 weeks for up to one year or until thedisease gets worse or the side effects become too severe.

    Participants ages 18 years or older who have been diagnosed with limited state small cell lung cancer. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03811002 STU00211222
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    Study Coordinator 312 695 1102
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    (xIRB) BMT CTN 1704: Composite Health Assessment Model for Older Adults: Applying Pre-transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplantation (CHARM)

    Thegoal of this study is to learn how to predict health after transplant, bas…

    Thegoal of this study is to learn how to predict health after transplant, based ontest results before transplant. The results may help doctors see if there is away to tell which participants will have better health after transplant. This study does not include any experimental procedures

    First allogeneic transplantation stem (cells are collected from a matching donor and transplanted into the participant to suppress the disease and restore the participant’s immune system) planned.

  • Participants must be 60 years old or older.
  • Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.
    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03992352 STU00211227
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

    The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful a…

    The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

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

    • Participantsmust be 18 years or older

    • Participants must have a confirmed diagnosis of cancermetastasized to the brain
    Kumthekar, PriyaKumthekar, Priya
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03994796 STU00211229
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB: ETCTN 10089: A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell Lymphomas

    The purpose of this study is to compare any good and bad effects of using CDX-1127 (varlilumab) along with anot…

    The purpose of this study is to compare any good and bad effects of using CDX-1127 (varlilumab) along with another immunotherapy drug, nivolumab. CDX-1127 (varlilumab) is an antibody that can stimulate the immune system to attack cancer tumor cells. Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system.

    The addition of CDX-1127 (varlilumab) to nivolumab could shrink your cancer but it could also cause side effects. This study will allow researchers to know whether the study approach is better, the same, or worse than nivolumab alone. To be better, the study drug combination should increase the proportion of the patients who have at least partial shrinkage of the tumors by 20 percent compared to the nivolumab only approach.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of B-celllymphomas that have come back after standard treatment or did not respond tothe standard treatment
    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St. Seventh Floor
      Chicago, IL
    NCT03038672 STU00211260
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB Alliance A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

    The purpose ofthis study is to compare the usual treatment of single fraction radiosurgery tousing fraction…

    The purpose ofthis study is to compare the usual treatment of single fraction radiosurgery tousing fractionated radiosurgery.This study will help the study doctors find outif this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if fractionated radiosurgery decreases the chances ofcancer coming back in the area where you had your brain surgery by 17.4% at oneyear compared to the usual approach of single fraction radiosurgery.

    This study has two groups. All study participants in each group will get radiosurgery.

    Group 1:Participants in this group will get the usual approach to treat the surgicalcavity with single fraction radiosurgery delivered in a single treatment.

    Group 2: Participants in this group will get fractionatedradiosurgery to the surgical cavity in three or five daily treatments, withsmaller cavities treated with 3 daily fractions and larger cavities treatedwith 5 daily treatments.

    After participants finish radiosurgery, they will befollowed for side effects for 2 years after treatment.

    Participants 18 years or older who have resected metastatic brain disease. 
    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04114981 STU00211282
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer (NIAGARA)

    There…

    Thereason for the study is to find more effective treatment for muscle invasivebladder cancer (bladder cancer that invaded the muscles of thebladder). AstraZeneca is doing thisresearch to find out if the medication called durvalumab combined with thestandard of treatment will work and be safe for the treatment of MuscleInvasive Bladder Cancer. Durvalumab has been approved by the FDA as therapy forthe treatment of locally advanced (cancer that has grown outside the bladder)or metastatic urothelial carcinoma (cancer that has spread outside of thelining of the urinary system), for patients whose cancers progressed during orafter platinum-based chemotherapy. Durvalumab has also been approved by the FDA and the EuropeanMedicines Agency (EMA) for the treatment of patients with locally advancednon-small cell lung cancer (cancer that has grown outside the lung cancer afterchemoradiation therapy).

    Participants must be 18 years of age or older

    Participants must be diagnosed with muscle invasive bladder cancer.

    VanderWeele, DavidVanderWeele, David
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03732677 STU00210539
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ETCTN 10170: A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies

    Participants who have a cancer which has grown or has recurred will be asked to participate in this study. The purpose of this study is to test any good and bad effects of the study drug ca…

    Participants who have a cancer which has grown or has recurred will be asked to participate in this study. The purpose of this study is to test any good and bad effects of the study drug called AZD1775 in tumors that have a mutation called SETD2. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size.

    All study participants will get the same study drug called AZD1775 until their disease gets worse, or the study drug causes side effects that cannot be managed with medications, or by changing the dose or schedule of the study drug.

    Participants ages 18 years of age or older who have a cancer that has grown or has recurred will be asked to participate in this study. 
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03284385 STU00211328
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    Study Coordinator 312 695 1102
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    DRUG PRELUDEDX : A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who ar…
    This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who are having genomic testing. This type of genomic testing looks athow certain genes are used by your tumor cells.
    The use of the DCISionRT DCIS test results in recommending treatment for your DCIS
    Kulkarni, SwatiKulkarni, Swati
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03448926 STU00210952
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    1-855-NU-STUDY
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    (xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comp…

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach. To decide if it is better,the study doctors will be looking to see if the addition of high-dose vitaminD3 to usual approach can shrink or stabilize tumors for a longer period of timethan regular-dose vitamin D3 and usual approach.

    This study has two groups:

    Group 1: Participants in this group will getthe usual drug regimen used to treat this type of cancer, either FOLFOX plusbevacizumab or FOLFIRI plus bevacizumab, plus a study drug called high-dosevitamin D3.

    Group 2: Participants in this group you willget the usual drug regimen used to treat this type of cancer, either FOLFOXplus bevacizumab or FOLFIRI plus bevacizumab, plus a study drug calledregular-dose vitamin D3.

    Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
    Kircher, SheetalKircher, Sheetal
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04094688 STU00211478
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ECOG-ACRIN 2182: A Randomized Phase II Study of De-Intensified ChemoRadiation for EarlyStage Anal Squamous Cell Carcinoma (DECREASE)

    This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the stud…

    This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach.

    This study has 2 studygroups.

    · Participants in groupA will get the standard dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 28 radiation treatment sessions in this group.

    · Group 2 (Arm B)

    Participants in group2 you will get the lower dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 20 or 23 radiation treatment sessions in this group, depending on thesize of the tumor.

    Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
    Kircher, SheetalKircher, Sheetal
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04166318 STU00211554
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    Study Coordinator 312 695 1102
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    ETCTN 10214: Immune Checkpoint Blockade for Kidney Transplant Recipients with Selected Unresectable or Metastatic cancers

    This study isbeing done to answer the following question:

    Can we safely andeffectively use nivolumab alone or with ipilimumab to treat cancer in patientswho have receive…

    This study isbeing done to answer the following question:

    Can we safely andeffectively use nivolumab alone or with ipilimumab to treat cancer in patientswho have received a kidney transplant?

    Nivolumab andipilimumab are a type of cancer therapy known as immunotherapy, whichstimulates the immune system to help the body fight cancer. Nivolumab and ipilimumab bind to proteinsfound on T cells (a type of white blood cell). This helps the immune system find and attack cancer cells. Nivolumab and ipilimumab are approved by theFood and Drug Administration (FDA) to treat many types of cancer, but in thistrial, they are considered experimental.

    We are doing this study because we want to findout if this immunotherapy approach is safe for kidney transplant recipients andwhether it is better or worse than the usual approach for your cancer. The usual approach is defined as the caregiven to most people with your cancer.

  • Participantsmust be 18 years or older

  • Participants must have a confirmed diagnosis of Kidneycancer and received a Kidney transplant
  • Sosman, JeffreySosman, Jeffrey
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03816332 STU00211560
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    1-855-NU-STUDY
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    NU 19C01: Understanding the Patient and Clinician Characteristics that Influence the Decision of Accepting Tumor Treating Fields (TTF) Therapy

    The purpose of this study is to better understand your choice to use or not use the Optune device for glioblastoma treatment. We would like to ident…

    The purpose of this study is to better understand your choice to use or not use the Optune device for glioblastoma treatment. We would like to identify the reasons for making your treatment decision and what characteristics may influence your decision.

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with glioblastoma and have beenoffered Tumor Treating Fields Therapy (TTF) and Optune therapy for treatment.

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00210799
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    Lacson, Leilani L +1 312 503 3463
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    DRUG D9103C00001: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Unresected Stage I/II, Lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

    This research is being done tofind out if the medication called durvalumab will work and be safe for thetreatment of patients with Stage I/II Non Small Cell Lung Cancer followingstereotactic body radiation therapy.

    If you choose to take part inthis study, after you complete stereotactic body radiation therapy you willreceive either durvalumab or placebo (a ’dummy treatment’ that looks like thestudy medication but contains no active ingredient) once a month for up to 24months.

    Durvalumab (called Imfinzi)is approved and recommended medicine forstage III NSCLC whose disease has not progressed following concurrentplatinum-based chemotherapy and radiation therapy (which is a more advancedform of the disease you have). Durvalumab is still in the development stage forthe treatment of an earlier stage of NSCLC, and is not approved for treatmentof stage I-II NSCLC, except for use in research studies like this.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of stageI/II Non small-cell lung cancer that has not been surgically removed and hasnot spread to the lymph node
    Mohindra, NishaMohindra, Nisha
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03833154 STU00211012
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    Study Coordinator 312 695 1102
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    Drug Vedolizumab-3035: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft-Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
    The main purpose of th…
    The main purpose of this research study is to investigate the safety and effectiveness of Vedolizumab compared to placebo (dummy drug), for prevention of intestinal aGvHD in patients undergoing allo-HSCT from an unrelated donor for a hematologic malignancy, (cancers that affect the blood and/or lymphaticsystem).

    Some of the eligibility criteria include:

    • Participants must not have prior allo-Hematopoietic Stem Cell Transplantation (HSCT).
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibilitycriteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.
    Moreira, JonathanMoreira, Jonathan
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03657160 STU00210880
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    Study Coordinator 312 695 1102
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    ECOG-ACRIN 4181: A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients = 70 years old with Untreated Mantle Cell Lymphoma

    This study isbeing done to answer the following question:

    Which combinationof cancer drugs most effectively treats your MCL?

    1. bendamustine, rituximab, and high dosecytarabine (BR/CR)

    2. bendamustine, rituximab, high dosecytarabine, and acalabrutinib (BR/CR-A)

    3. bendamustine, rituximab andacalabrutinib (BR-A)

    We are doing this study because we want to findout if one of these drug combinations is better or worse than the usualapproach for your MCL. The usual approach is defined as care most people getfor MCL. Acalabrutinib is investigational for treating newly diagnosed MCL. Itis Food and Drug Administration (FDA) approved for MCL that has not respondedto treatment or relapsed
    • Participants must be 18 years orolder and ≤ 70 years old
    • Participants must have a confirmed diagnosis of MantleCell Lymphoma which has not been treated
    Karmali, ReemKarmali, Reem
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04115631 STU00211660
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG PACT-0001: A Prospective Observational Cohort Study of Changes in the Neoepitope Specific T Cell Repertoire in Patients with Cancer
    the interaction betweenyour immune system and your cancer. This will help researchers understand howyour immune system and cancer adapt to current cancer tr…
    the interaction betweenyour immune system and your cancer. This will help researchers understand howyour immune system and cancer adapt to current cancer treatments.Notreatments will be administered in this non-interventional study.

    1. Participants ≥ 18years of age with stage III-IV or locally advanced or metastatic disease.

    2. Histologically or cytologicallydocumented incurable or metastatic solid tumors

    Sosman, JeffreySosman, Jeffrey
    • Map it 233 E. Superior St. First Floor
      Chicago, IL
    STU00211661
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    Study Coordinator 1-855-NU-STUDY
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    NU 19H08: 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 (ET). …
    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.
    • Patients must have a diagnosis of either polycythemia vera (PV) or essential thrombocytosis (ET)
    • Patients must be age 18 years or older.
    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211647
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    Study Coordinator 312 695 1102
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    A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL)
    This research study involves studying whetherdifferent dosing schedules of a new drug calledduvelisib or VS-0145 can be used to treat indolentNon…
    This research study involves studying whetherdifferent dosing schedules of a new drug calledduvelisib or VS-0145 can be used to treat indolentNon-Hodgkin Lymphoma (iNHL) that has comeback or that has not responded to standardtreatment. iNHL includes other subtypes oflymphomas known as follicular, marginal zone,and small cell lymphoma. Duvelisib is a drugdesigned to stop cancer growth by blocking PI3kinase activity. PI3 kinase is an enzyme in thebody that is overproduced by some cancers andcan fuel cancer growth. PI3 kinase activity isknown to be increased in many blood cancers.Duvelisib was approved (available to beprescribed or sold) by the Food and DrugAdministration (FDA) in September 2018 for thetreatment of patients with follicular lymphoma thathas come back or that has not responded to twostandard treatment and also a different type ofcancer known as chronic lymphocyticleukemia/small lymphocytic lymphoma (CLL/SLL)that has come back or that has not responded totwo standard treatment.The dose of duvelisib (study drug) currentlyapproved for treatment is 25 mg twice a day. Thisstudy is evaluating the use of different dosingschedules in patients with iNHL that are notcurrently in the US Prescribing Information.
    Participants must be 18 years or older• Participants must have a confirmeddiagnosis of indolent Non-HodgkinLymphoma (iNHL)• Participants must have received at leastone previous treatment for iNHL• Participants must have iNHL that hasworsened over time.
    Gordon, Leo I IGordon, Leo I I
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04038359 STU00211732
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    Study Coordinator 312 695 1102
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    BTCRC BRE18-337: Phase 2 Trial with Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

    Researchers think that combining talazoparib and gedatolisib will havemore benefits than giving either drug on its own. This study is bein…

    Researchers think that combining talazoparib and gedatolisib will havemore benefits than giving either drug on its own. This study is being done tofind the safe dose of talazoparib combined with gedatolisib and to find out ifthe combination has any effect on triple negative breast cancer.

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with advanced breast cancer that has spread to other parts of you body.

    -Participants must have either a type of breast cancer called “triplenegative” without a BRCA1/2 gene mutation or human epidermal growth factorreceptor 2 (HER-2) negative breast cancer with a BRCA1/2 gene mutation

    Shah, AmiShah, Ami
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03978611 STU00211191
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    Study Coordinator 312 695 1102
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    DRUG CKAZ954A12101: A Phase I/IB, Open-label, Multi-Center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients with Advanced Solid Tumors
    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartaliz…
    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.
    All patients age 18 and above who have advanced cancers are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04237649 STU00211372
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    Study Coordinator 312 695 1102
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    (xIRB NCI CIRB) SWOG 1900C: A PHASE II STUDY OF TALAZOPARIB PLUS AVELUMAB IN PATIENTS WITH STAGE IV OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER BEARING PATHOGENIC STK11 GENOMIC ALTERATIONS (LUNG-MAP SUB-STUDY)

    This study isbeing done to answer the following question:

    Can we increa…

    This study isbeing done to answer the following question:

    Can we increasethe ability of your immune system to fight lung cancer and lower the chance ofyour lung cancer growing or spreading by using a combination of talazoparib andavelumab?

    We are doing this study because we want to findout if this approach is better or worse than the usual approach for yournon-squamous non-small cell lung cancer. The usual approach is defined as care most people get for theirnon-squamous non-small cell lung cancer.

    • Participants must be 18 years orolder
    • Participants must have a confirmed diagnosis of StageIV or recurrent Non-Small Cell Lung Cancer (NSCLC)
    Chae, Young KwangChae, Young Kwang
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00211749
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    Study Coordinator 312 695 1102
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    DRUG 20170528: A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
    This study is being done to find out if the study drug, AMG 427 is safe when given to patients with…
    This study is being done to find out if the study drug, AMG 427 is safe when given to patients with AML and to understand its side effects.
    All patients 18 and above who have acute myeloid leukemia (AML) that has come back (relapsed) or is not responding to treatment (refractory).
    Altman, Jessica KAltman, Jessica K
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03541369 STU00210905
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG BNT411-01: Phase 1/2a, First-In-Human, Open-label, Dose-escalation Trial With Expansion Cohorts To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Efficacy Of Bnt411 As A Monotherapy In Patients With Solid Tumors And In Combination With Atezolizumab, Carboplatin And Etoposide In Patients With Chemotherapy-Naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC)
    The purpose of this research study is to establish a safe dose of the research study drug called BNT411. This study has two parts: 1A and 1B. Part 1A will include participants with various types of solid tumors that have either spread in the body (metastatic) or that cannot be removed by surgery (unresectable). Part 1B will include participants who have extensive–stage small cell lung cancer (EC-SCLC) that has not been treated by chemotherapy before. If you meet all the criteria for being in the study, BNT411 will be given as an intravenous (IV) infusion.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    Treatment regimen for part 1A:

    Participants will receive BNT411 alone (monotherapy) as an infusion (a drip) into the vein (so called i.v. infusion). This will last about 30 minutes. The infusion will be given on days 1, 8 and 15 of each 3-week cycle for the first four cycles. From the 5th cycle onwards, participants will receive BNT411 only on day 1 of each 3-week treatment cycle.

    Treatment regimen for part 1B:

    Participants will receive BNT411 in combination with other anti-cancer medicines (atezolizumab, carboplatin and etoposide).

    Participants will get BNT4111 via i.v. infusion lasting about 30 minutes on days 2, 8 and 15 of each 3-week treatment cycle for the first four cycles. From the 5th cycle onward, participants will get BNT411 only on day 2 of each 3-week treatment cycle.

    The order of administration will be as follows:

    Day 1: atezolizumab -> carboplatin -> etoposide

    Day 2: BNT411 -> etoposide

    Day 3: etoposide

    Atezolizumab, carboplatin, and etoposide will be also given via i.v. infusion. The first atezolizumab infusion will last about 60 minutes and subsequent infusions may be shortened to 30 minutes if the first one was well tolerated. Carboplatin infusions may last between 30 – 60 minutes. Etoposide infusions will last over 60 minutes. The doses of these medicines will be as per standard of care.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Either:

    oDiagnosis solid tumors that have either spread in the body (metastatic) or that cannot be removed by surgery (unresectable) or

    oDiagnosis of extensive–stage small cell lung cancer (EC-SCLC) that has not been treated by chemotherapy before

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04101357 STU00211880
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    Study Coordinator 312 695 1102
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    DRUG CA013-004: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors
    The purpose of the study is to test the safety and anti-tumor activity of a new drug called BMS-986179 (also known as anti-CD73) administered alone…
    The purpose of the study is to test the safety and anti-tumor activity of a new drug called BMS-986179 (also known as anti-CD73) administered alone and in combination with nivolumab (also known as BMS-936558).

    You may be eligible for this research study if you have an advanced solid tumor, renal cell cancer (RCC).

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02754141 STU00211357
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB SWOG 1922: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

    Thisstudy is being done to answer the following question:

    Can we find out if one or both of two different chemotherapy treatments(Ramucirumab plu…

    Thisstudy is being done to answer the following question:

    Can we find out if one or both of two different chemotherapy treatments(Ramucirumab plus Paclitaxel versus FOLFIRI) is helpful in treating your smallbowel cancer? If both are helpful, canwe find out which is better?
    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of earlystage (stage 2) of colon cancer at the time of surgery

    Note: This is only a partial list of eligibility criteria. Pleasecontact the Robert H. Lurie Comprehensive Cancer Center of NorthwesternUniversity for complete screening information if you are interested in thisclinical trial.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04205968 STU00211958
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    Study Coordinator 312 695 1102
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    PCCTC c17-191: CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone, A Phase 2 Study of Carboplatin, Cabazitaxel and Abiraterone in Metastatic Castrate Sensitive Prostate Cancer with and without DNA Repair Mutations

    The purpose of this study isto determine if giving carboplatin a…

    The purpose of this study isto determine if giving carboplatin and cabazitaxel, followed by abirateroneimproves cancer control as measured by prostate-specific antigen (PSA) level and disease assessment scans. PSA levels may indicate the presence of prostate cancer. Cancer that has spread beyond the prostate may become difficult to treat. The drugs used in this study are approved by the United States Food and Drug Administration (FDA) for the treatment of cancer; however the combination is not standard and cabazitaxel is approved only for advanced prostate cancer. Carboplatin is an older drug and often used for the treatment of prostate cancer, although it is only FDA approved for ovarian cancer. For this reason,cabazitaxel and its use with carboplatin is considered investigational.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    You will receive carboplatin and cabazitaxel treatment over approximately 4 ½ months (once every 3 weeks).Within 4 weeks of completing carboplatin and cabazitaxel treatment, you will receive abiraterone and be seen approximately every 3 months for a disease reassessment for up to 2 years. Study participation will end early if you have a worsening of your disease or need a change in treatment.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Diagnosis of metastatic, castration-resistant prostate cancer

    Age of at least 18 years

    VanderWeele, DavidVanderWeele, David
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03934840 STU00211376
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB ECOG-ACRIN 5163: EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis

    The purpose of this study is to compare any good and bad effects of using only the immunotherapy drug, MK-3475 (pembrolizumab), alone first versus the combination of the immunotherapy drug, MK-3475 (pembrolizumab), and chemotherapy. This study will also compare if adding chemotherapy to immunotherapy when the disease is growing is helpful. The addition of chemotherapy regimens to the usual immunotherapy could shrink cancer or prevent it from returning.

    This study will help the study doctors find out if this different approach is better, the same, orworse than the usual approach. The study doctors are looking to see if the study approach reduces the number of side effects compared to the usual approach without affecting life expectancy. They also hope that it will increase the life of patients by 5 months or more compared to the usual approach.

    This immunotherapy drug, MK-3475 (pembrolizumab), is already approved by the FDA for use in metastatic lung cancer whose tumors express high levels of PD-L1 or when chemotherapy has stopped working.

    This study has 3 study groups.

    Group 1

    Participants in this group will get the immunotherapy drug, MK-3475 (pembrolizumab), for up to 2years, unless their disease gets worse sooner than 2 years or the side effects become too severe.

    Group 2

    Participants in this group will get the immunotherapy drug, MK-3475 (pembrolizumab), for up to 2years, unless their disease gets worse sooner than 2 years or the side effects become too severe.

    Group 3

    Participants in this group will get the immunotherapy drug, MK-3475 (pembrolizumab), and the chemotherapy drugs, pemetrexed and carboplatin until their disease gets worse or the side effects become too severe.

    Participants who are 18 years or older who have non-squamous non-small cell lung cancer that hasspread outside their lungs.

    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03793179 STU00211971
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    Study Coordinator 312 695 1102
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    (xIRB) NCI CIRB SWOG 1900B: A Phase II Study of LOXO-292 in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
    Participants who have non-small cell lung cancer that has spread outsideof their lungs and who have a tumor sample that is positive for a…
    Participants who have non-small cell lung cancer that has spread outsideof their lungs and who have a tumor sample that is positive for a RET fusion willbe asked to participate in this study. The purpose of this study is to test the good and bad effects of the drugcalled LOXO-292. LOXO-292 could shrink cancer. The study doctors hope to learnif the treatment will shrink the participant's tumor. Another purpose of thisstudy is for the study doctors to learn if a biomarker test for RET fusions ishelpful in assigning treatment.LOXO-292 is not approved by the FDA for use in advanced non-small cell lungcancer. For this treatment study, participants will be assigned to treatment with aninvestigational drug called LOXO-292. Participants will take LOXO-292 bymouth twice daily for each cycle. Each cycle is 28 days long. Participants willget the study drug LOXO-292 daily until their disease gets worse, the sideeffects become too severe, or they desire to discontinue the studyAfter participants finish study treatment, their doctor will continue to followtheir condition for up to three years from the time they went on study andwatch them for side effects. If their disease has not gotten worse, follow upvisits will occur every 3 months. If their disease has gotten worse, follow upvisits will occur every 6 months for 2 years, and then at the end of the 3years from the time they went on study.
    Participants 18 years of age or older who have RETFusion-Positive Advanced Non-Small Cell Lung Cancer will be enrolled into this study.

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211972
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    Study Coordinator 312 695 1102
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    NRG LU006: Phase III Randomized Trial of Pleurectomy/Decortication Plus Chemotherapy with or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) For Malignant Pleural Mesothelioma (MPM)

    This study isbeing done to answer the following question: Can we extend your l…

    This study isbeing done to answer the following question: Can we extend your life by addingradiation therapy to the lining of the lung to the usual treatment of surgeryand chemotherapy?

    We are doing this study because we want to findout if this approach is better or worse than the usual approach for yourcancer. The usual approach is defined ascare most people get for MPM.

    · Participantsmust be 18 years or older

    Participants must have a confirmed diagnosis MalignantPleural Mesothelioma (MPM)
    Kruser, TimothyKruser, Timothy
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00211980
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    Study Coordinator 312 695 1102
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    SWOG 1827: A Randomized Phase III Trial of MRI Surveillance with or Without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer

    This study is being done to answer the following question:

    Does the use of brain scans alone instead of brain scans plus preventive brain radiation a…

    This study is being done to answer the following question:

    Does the use of brain scans alone instead of brain scans plus preventive brain radiation affect the lifespan of patients with small cell lung cancer?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach. The usual approach is defined as care that most people get for small cell lung cancer.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis Small-CellLung cancer
    Kruser, TimothyKruser, Timothy
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00211982
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    Study Coordinator 312 695 1102
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    NU 19U02: A Single Arm Phase II Trial of Neoadjuvant Niraparib in Men with Localized Prostate Cancer and a Low Androgen Receptor (AR)-Activity Signature

    Niraparib is an investigational new oral drug that is thought toinhibit the enzymatic activity of a family of proteins in the cell called Poly(AD…

    Niraparib is an investigational new oral drug that is thought toinhibit the enzymatic activity of a family of proteins in the cell called Poly(ADP-ribose) Polymerase (PARP; which includes PARP1 and PARP2). PARP enzymesare involved in a variety of processes needed for the cell to remain healthy,such as stability of its genome (complete set of DNA which contains all theinformation needed for the cell to function) and repair the DNA when damaged.BRCA1 and BRCA2 belong to another family of proteins that are important forreparing damaged DNA. Inhibiting DNA repair in cancer cells can force thecancer cell to die.

    Previous studies have suggested that prostate cancers that havedecreased Androgen Receptor (AR; a protein which binds to the male hormonescalled androgens) function and/or defective BRCA1 or BRCA2 proteins are moreeasily killed by PARP inhibition. This research is being done to investigatewhether Niraparib can help suppress the growth or delay the worsening of yourprostate cancer.

    This study has two parts: 1) pre-screeing and;2) Treatment (main). In order to be eligible for the study, you must undergopre-screening procedures. Two groups of patients will become eligible toparticipate in this study based on the initial pre-screening results, which include:Group 1) patients who have low androgen receptor (AR) activity and; Group 2)those who have completed AR activity testing (can be AR-A-low or AR-A-high) andhave known mutations in the BRCA1 or BRCA2 protein. Depending on the pre-screenresults you may be assigned to one of the above two groups.

    · Participants must be 18 years orolder

    Participants must be diagnosed with localizedprostate cancer
    VanderWeele, DavidVanderWeele, David
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00211536
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    Study Coordinator 312 695 1102
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    (xIRB) DRUG IMGN632-0802: A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

    The purposes of this research study are:

    •To combine IMGN632 (study drug), an experimental drug, with standard th…

    The purposes of this research study are:

    •To combine IMGN632 (study drug), an experimental drug, with standard therapies (azacitidine and/or venetoclax).

    •To find out what effects, both good and/or bad, the combination of study drug (IMGN632) and standard therapy (azacitidine and/or venetoclax) may have on you and your type of cancer.

    •To find a safe dose of IMGN632 to use in combination with azacitidine and/or venetoclax.

    •To find out how well IMGN632 works with combination therapies (azacitidine and/or venetoclax) to treat your type of cancer.

    •Alternatively, if you are in complete remission but have a very small amount of leukemia detectable (called minimal residual disease positive, MRD+) after the previous treatment, this study will see if IMGN632 can make your disease no longer detectable.

    If you meet all the eligibility criteria for being in this study, you will be assigned to one of four different groups:

    •Combination A: IMGN632 + azacitidine

    •Combination B: IMGN632 + venetoclax

    •Combination C: IMGN632 + azacitidine + venetoclax

    •Combination D: IMGN632

    All prospective participants will undergo screening tests to determine if they are eligible to take part in the study. You will be assigned to one of the four study treatment groups in the study.

    •Combination A (IMGN632 + azacitidine): Azacitidine is given daily for 7 days, IMGN632 is given on day 7 after the last azacitidine dose. After day 7, no study drug is given for the rest of the cycle. Each cycle in Regimen A is 28 days.

    •Combination B (IMGN632 + venetoclax): Venetoclax is taken daily for 21 days. IMGN632 is given on day 7 after the seventh venetoclax dose. Each cycle in Regimen B is 21 days.

    •Combination C (IMGN632 + azacitidine + venetoclax): Venetoclax is taken daily for 28 days. Azacitidine is given daily for 7 days. IMGN632 is given on day 7 after the seventh azacitidine and venetoclax doses. Each cycle in Regimen C is 28 days.

    •Combination D (IMGN632): IMGN632 is given every 21 days. Each cycle in Regimen D is 21 days.

    Note: This is only a partial description of study treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete study treatment information if you are interested in this clinical trial.

    Some of the eligibility criteria include:

    •Diagnosis of Acute Myeloid Leukemia (AML) that has not responded fully to treatment or has come back after treatment or you have untreated AML but a clinical trial may be appropriate

    •Age of at least 18 years

    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.

    Altman, Jessica KAltman, Jessica K
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04086264 STU00212068
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    Study Coordinator 312 695 1102
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    (xirb) Drug EZH-1201: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies
    Tazemetostat (EPZ-6438) is an experimental study drug that has not yet been approved. This study intends to f…
    Tazemetostat (EPZ-6438) is an experimental study drug that has not yet been approved. This study intends to find out what effects, good and/or bad, it has on you and in the treatment of your cancer. 
    You may be eligible to take part in this study if you have advanced cancer that has spread to different parts of your body after receiving certain types of therapy. 
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04241835 STU00212081
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    Study Coordinator 312 695 1102
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    (xirb) DRUG SMX 18001 : An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation Study
    The purpose of this resear…
    The purpose of this research study is to compare the effects of a drug called fulvestrant to theeffects of a drug called lasofoxifene on breast cancer. This study will determine if the timeto progression while receiving lasofoxifene improves compared to fulvestrant withoutincreasing side effects. 
    Breast cancer that has spread and has stopped responding to current treatment. 
    Shah, AmiShah, Ami
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03781063 STU00212362
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    1-855-NU-STUDY
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    ECOG-ACRIN 2183: A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

    This study is being done to answer the following question:

    Will adding radiotherapy after the usual combination of drugs used to treat o…

    This study is being done to answer the following question:

    Will adding radiotherapy after the usual combination of drugs used to treat oligometastatic esophageal and gastric adenocarcinoma help you live longer?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your esophageal cancer or gastric adenocarcinoma. The usual approach is defined as care most people get for oligometastatic esophageal and gastric adenocarcinoma.

    · Participantsmust be 18 years or older

    Participants must have a confirmed diagnosis of Gastricor Her2-negative esophageal cancers
    Hayes, John PHayes, John P
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04248452 STU00212379
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    Study Coordinator 312 695 1102
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    NRG GY020: A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

    The purpose of this study is to compare the usual treatment alone (radiation) to using the us…

    The purpose of this study is to compare the usual treatment alone (radiation) to using the usual treatment plus pembrolizumab (immunotherapy). The addition of pembrolizumab to the usual treatment could reduce the risk of cancer coming back.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of pembrolizumab to radiation treatment reduces the risk of cancer coming back from approximately 20% to approximately 5% at 3 years.This immunotherapy drug, pembrolizumab (Keytruda®), is already approved by the FDA for use in several other types of cancer (e.g. melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancers, and also in cervical cancer and endometrial cancer that has come back after treatment with chemotherapy). This study has 2 study groups. Participants will either get radiation for 2-6 weeks or radiation for 2-6 weeks and immunotherapy every 3 weeks for up to one year, unless cancer returns sooner or the side effects become too severe.After participants finish treatment on the study, study doctor will continue to follow one's condition and watch for side effects. They will evaluate participants' health at clinic visits every 3 months for 2 years after finishing treatment. After that, they will continue to check participants' health with clinic visits every 6 months for 3 years.

    • Diagnosis of Stage I endometrioid endometrial cancer OR Stage II endometrioid endometrial cancer
    • At least 18 years old.
    Barber, EmmaBarber, Emma
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04214067 STU00212389
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    Study Coordinator 312 695 1102
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    ECOG-ACRIN 2187: A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma

    This study is being done to answer the following question:

    How well does treatment with the study drug, pevonedistat, stop your cancer from getting wors…

    This study is being done to answer the following question:

    How well does treatment with the study drug, pevonedistat, stop your cancer from getting worse when taken alone and in combination with chemotherapy?

    We are doing this study because we want to find out if this approach can control advanced intrahepatic cholangiocarcinoma (also known as bile duct cancer). For this type of cancer there is not a standard type of chemotherapy that is shown to be highly effective for this cancer once someone has already tried one type of chemotherapy. The usual approach is defined as care most people get for advanced intrahepatic cholangiocarcinoma.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis of advancedcholangiocarcinoma (bile duct cancer)
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04248452 STU00212424
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    Study Coordinator 312 695 1102
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    DRUG RAIN-701: A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions
    The purpose of this research stud…
    The purpose of this research study is to gather data that will be used to evaluate the safety and effectiveness of the investigational drug, Tarloxotinib. Tarloxotinib is an investigational drug, meaning the study drug is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) or Health Canada (HC). Tarloxotinib is used in patients with NSCLC or other advanced solid tumors. The study is being done to evaluate the response rate of Tarloxotinib. The study is also being done to see how Tarloxotinib controls the tumor, how long the tumor responds, how the drug controls the cancer, and to determine progression-free survival and overall survival rates. The study is being done to investigate the pharmacokinetics (PK) of Tarloxotinib. Pharmacokinetics is the study of how long the study drug stays in your blood, and how your body gets rid of the drug.

    If you meet all the criteria for being in the study, Tarloxotinib will be given as an intravenous (IV) infusion using an IV infusion or syringe pump (IV pump).

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Tarloxotinib will be given as an intravenous (IV) infusion using an IV infusion or syringe pump (IV pump). It will be given every week, approximately every 6 to 8 days. The dose level will be based on height and weight, as well as tolerance to the study treatment when given previously. Study treatment will be given in “cycles”; a cycle is a 28-day period. The study treatment will be given on the 1st, 8th, 15th, and 22nd day of every 28-day cycle

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Either:

    o Diagnosis of non-small cell lung cancer (NSCLC), Stage IV, Stage IIIB, or III C, and the cancer is not responding to curative-intent therapy or

    o Recurrent NSCLC after a prior diagnosis of Stage I-III or

    o Locally advanced or metastatic solid tumor

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03805841 STU00211888
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    Study Coordinator 312 695 1102
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    NU COVID-19 INT20L02 - International registry on thoracic cancer patients with COVID 19 - TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion)
    An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to …
    An early report of COVID-19 cases indicated that cancer patients had an increased risk of developing severe COVID-19-related symptoms compared to COVID-19 patients without cancer. The purpose of this registry is to collect clinical information like symptoms, treatments, and outcomes of thoracic cancer patients (NSCLC, SCLS, MPM, and TETs) with COVID-19 to help develop risk assessment strategies and treatment recommendations for thoracic cancer patients.

    Participants 18 years or older who have a type of thoracic cancer; (Non-Small Cell Lung Carcinoma [NSCLC], Small CellLung Carcinoma [SCLC], Malignant Pleural Mesothelioma [MPM], or thymicepithelial tumor [TET]) and have also been diagnosed with COVID-19

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212311
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    Study Coordinator 312 695 1102
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    NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior …
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.

    Primary Aim:

    To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

    Secondary Aims:

    To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

    To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

    To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

    Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.
    Ma, ShuoMa, Shuo
    • Map it 251 E. Huron St.
      Chicago, IL
    STU00212455
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    Study Coordinator 312 695 1102
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    NU 19H11 - Identifying Molecular Markers That Predict Relapse After Therapy Discontinuation In Chronic Myeloid Leukemia

    Many patients with CML have long term “complete molecular” remissions with tyrosine kinase

    inhibitor drugs (such as imatinib or dasatinib). This refers to the inability…

    Many patients with CML have long term “complete molecular” remissions with tyrosine kinase

    inhibitor drugs (such as imatinib or dasatinib). This refers to the inability to detect any leukemia

    in the blood or bone marrow. Some patients with a complete molecular remission can stop

    treatment, but 50% of those who do will have their CML return within 2-3 years. We do not

    currently have a way to predict which patients will relapse (cancer returns) versus remain in

    sustained remission (all signs and symptoms of cancer have disappeared) after stopping

    therapy. The purpose of this study is to examine blood or bone marrow cells from patients with

    CML who are stopping treatment. By doing this study, we hope to identify characteristics of

    blood cells that predict the likelihood of relapse after stopping therapy.

    • 18-85 years of age
    • confirmed diagnosis of Chronic Myeloid Leukemia (CML) that meets the criteria for stopping therapy because of long term "complete molecular" remission
    • previous treatment with any tyrosine kinase inhibitor (TKI) drugs
    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212526
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    Study Coordinator 312 695 1102
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    NU FC19L02: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked
    The purpose of this research study is to determine if the combination therapy of carboplati…
    The purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization.

    •Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

    •Arm B: Carboplatin + Pemetrexed + Avastin

    Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase.

    Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase.

    Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study.

    All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Stage IV advanced non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation or without a history of smoking

    •Age of at least 18 years

    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.

    Patel, Jyoti D DPatel, Jyoti D D
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03786692 STU00211923
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    Study Coordinator 312 695 1102
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    RTOG 1308: Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIb NSCLC

    Radiation therapy is used to treatlung cancer when surgery is not an option. There are two types of radiation treatments used for lung cancer. …

    Radiation therapy is used to treatlung cancer when surgery is not an option. There are two types of radiation treatments used for lung cancer. One type of treatment is photon therapy,which uses high-engergy x-rays to send the radiation inside the body to thetumor. Thisis the usual radiation treatment approach for your type of lung cancer. The other type of ratiation is proton therapy, which uses abeam of proton particles to send radiation inside the body to the tumor. Thisis the type of radiation therapy being studied in this trial. Both types ofradiation treatment use special images to help guide accurate delivery of afull dose of radiation to the tumor without damaging much of the healthy tissuearound it.

    The purposeof this study is to compare the good and bad effects in terms of patient lifespan after these two different types of radiation therapy in combination withFDA-approved chemotherapy for your type of lung cancer. For lung cancer, protontherapy is relatively new compared with x-ray therapy, so we do not know ifproton therapy is beneficial or not. Compared withphotons, proton therapy can stop shortly after penetrating through the tumorand therefore may cause less damage to the surrounding healthy organs and mayresult in better survival due to reduced damage to the surrounding healthyorgans. This feature of proton therapy may also allow doctors to deliver higherdoses of radiation to the tumor.

    ·

    Note: This is only apartial list of eligibility criteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.
    Gentile, MichelleGentile, Michelle
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT01993810 STU00212687
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    Study Coordinator 312 695 1102
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    CCTG CE.7: A phase III trial of stereotactic radiosurgery compared with hippocampal-avoidant whole brain radiotherapy (ha-wbrt) plus memantine for 5-15 brain metastases

    This study is being done to answer the following question: Can we reduce your symptoms and lower the chance of the cancer growing…

    This study is being done to answer the following question: Can we reduce your symptoms and lower the chance of the cancer growing or getting worse by using stereotactic radiosurgery, compared to the usual radiotherapy? Stereotactic radiosurgery or SRS is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for cancer that has spread to the brain

    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.

    Kruser, TimothyKruser, Timothy
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT03550391 STU00212914
    More Info

    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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    DRUG CX-839-012: A Phase 1b/2, Open label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with the CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors
    The purpose of this study is to determine a safe and tolerable d…
    The purpose of this study is to determine a safe and tolerable dose of telaglenastat (an “investigational” drug), given together with palbociclib (an “approved” drug),  
    All participants in Part 2 of the study must be 18 years of-age or older and be diagnosed with advanced or metastatic CRC or NSCLC.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03965845 STU00212083
    More Info

    For more information on this study please contact us:

    1-855-NU-STUDY
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