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Trials
NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to…
RATIONALE: 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. PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
Salem, RiadSalem, Riad
NCT00530010 STU00011036
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A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass b…
RATIONALE: 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. PURPOSE: 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.
Salem, RiadSalem, Riad
NCT00532740 STU00011037
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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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1-888-NU-STUDY
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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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DRUG TS-102: A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy
The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases …
The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.
Mulcahy, Mary FrancesMulcahy, Mary Frances
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01483027 STU00059821
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Study Coordinator 312 695 1102
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A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well …
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
Dokucu, Mehmet EDokucu, Mehmet E
NCT01701284 STU00063218
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Fairchild, Melody Dawn 312 503 7071
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The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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Khawaja, Faizan 312 694 2417
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ECOG N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
RATIONALE: Drug…
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, 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 alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer. PURPOSE: This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.
Halverson, Amy LHalverson, Amy L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01515787 STU00067473
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Study Coordinator 312 695 1102
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Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal …
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal therapy, and how these brain areas are related to the development of mild cognitive impairment as the results of these treatments. This study involves obtaining pictures of the brain’s size, shape and activity using a Magnetic Resonance Imaging (MRI) device, a machine that uses a powerful magnet to obtain this information without using any radiation. This procedure has been used safely with humans in many different studies. Your part in this study will last for 1 to 2 years.
Female breast cancer patients between 40-70 years old
Wang, LeiWang, Lei
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT01949376 STU00069634
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Berger, Jessica M 312 503 4995
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NU 12G11: The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tiv…
This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Matei, DanielaMatei, Daniela
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01853644 STU00073756
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Study Coordinator 312 695 1102
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SWOG 1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer, e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Flaum, LisaFlaum, Lisa
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01674140 STU00082264
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Study Coordinator 312 695 1102
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RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01872975 STU00083782
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Study Coordinator 312 695 1102
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NU 13S02: Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is fo…
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02048722 STU00087654
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Study Coordinator 312 695 1102
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Epigenetic Markers of Bladder Cancer Progression
The purpose of this study is to better understand the expression of certain genes and genetic changes that occur in bladder tumors.
Male or female patients aged 40-89 identified to have a bladder lesion or mass concerning for urothelial carcinoma based on cystoscopy or imaging who are scheduled to undergo transurethral resection of bladder tumor (TURBT).
Meeks, Joshua JMeeks, Joshua J
STU00088853
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Meeks, Joshua J 312 695 8146
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A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
This study is a prospective Phase IV study to determine if the …
This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Kulik, Laura MKulik, Laura M
NCT02081755 STU00083409
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Bezler, Laura 312 694 0260
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B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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Wolfe, Kaitlin A 312 503 3248
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NU SARC14S01: A blanket protocol to study oral regorafenib in patients with selected sarcoma subtypes
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been …
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02048371 STU00094754
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Study Coordinator 312 695 1102
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DRUG ATI001-102: A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
This research study involves two investigational drugs…
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02026271 STU00094296
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Amidei, Christina 312 695 9124
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ECOG 1910: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults.
Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview …
Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview This study is for patients who have recently been diagnosed with a subtype of ALL that is known as BCR-ABL negative B-lineage ALL. Blinatumomab is a new antibody therapy that binds to B cells and recruits T cells to attack leukemia B cells. Patients will be randomized to receive chemotherapy what has traditionally been used to treat this sub-type of ALL alone or chemotherapy with blinatumomab . Studies are being done in ALL and other blood cancers with blinotumomab Blinatumomab has been effective in residual or relapsed B-cell ALL at destroying these specific cells. But it has not yet been proven helpful in combination with chemotherapy in newly diagnosed ALL. Description of Treatment There are several steps of treatment in this study. They are called induction, intensification, consolidation, and maintenance. In these study steps participants will be getting standard chemotherapy treatments that may or may not be combined with a new cancer drug called blinatumomab. Blinatumomab is a drug that is given as a continues infusion. The treatment schedule should be discussed with the study doctor.
Some of the eligibility criteria include:

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

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

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

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cella, DavidCella, David
  • Map it 201 E. Huron St.
    Chicago, IL
STU00070200
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Study Coordinator 312 695 1102
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A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
This randomized phase III trial studies how well crizotinib works and compare…
This randomized phase III trial studies how well crizotinib 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 fusion mutation.
Mohindra, NishaMohindra, Nisha
NCT02201992 STU00102000
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1-855-NU-STUDY
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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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ECOG-ACRIN S1400: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assi…
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02154490 STU00100140
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Study Coordinator 312 695 1102
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A prospective, randomized, blinded, placebo-controlled, phase IIb trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine vs unloaded YCWP + DC in stage III and stage IV (resected) melanoma to prevent recurrence
The majority of melanoma…
The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02301611 STU00200122
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Study Coordinator 312 695 1102
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NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
There are two study questions the investigators are asking in this randomized phase II/III trial b…
There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Mittal, Bharat BMittal, Bharat B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02135042 STU00200330
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Study Coordinator 312 695 1102
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NU 14S03: A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The…
The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The safety of this drug combination will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02357810 STU00200112
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Study Coordinator 312 695 1102
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Alliance A081105: Randomized Study of Erlotinib vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Purpose The purpose of this study is to compare any good and bad effects patients may have when treated with the st…
Purpose The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). Overview This study is for patients with early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). Researchers are trying to find out if this mutation could help doctors make decisions about which type of treatment is best for people with this type of cancer. People not in a research study are usually not treated with anything after they finish their chemotherapy although some of them may receive radiation therapy. Description of Treatment This study has two study groups. Group 1 will get the study drug called erlotinib. The erlotinib will be taken once a day. Group 2 will get the placebo, which looks just like the erlotinib but does not have any active ingredients. The placebo will be taken once a day.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02193282 STU00200145
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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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A Phase 2 Study of MM-121 in Combination with Docetaxel or Pemetrexed versus Docetaxel or Pemetrexed alone in Patients with Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to determine whether the combination of MM-121 plus doce…
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to PFS in patients with heregulin-positive NSCLC.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02387216 STU00200295
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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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Lipiszko, Olga 312 503 6568
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NU 14H09: A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients with MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen
The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it…
The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Pro, BarbaraPro, Barbara
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02481310 STU00200596
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Study Coordinator 312 695 1102
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A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination with Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer
The study seeks to assess the efficacy of veliparib (ABT-888) in combination wit…
The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin, with or without the involvement of regional lymph nodes, including ipsilateral and contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular nodes
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02289690 STU00200750
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Study Coordinator 312 695 1102
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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 Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
Purpose The main purpose of this study is to compare the usual approach (i.e. capecitab…
Purpose The main purpose of this study is to compare the usual approach (i.e. capecitabine), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery - in patients with triple negative breast cancer with residual basal-like disease who have received neoadjuvant chemotherapy. Overview Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV breast cancers, but are usually not used in patients with early forms of breast cancer. The use of a platinum-based chemotherapy could prevent the cancer from returning (metastatic recurrence), 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. Description of Treatment Study participants will be randomly assigned by chance (like the flip of a coin) to one of the two study groups. Group 2 will get a platinum-based chemotherapy treatment for 12 weeks. Participants will receive a 30-minute intravenous infusion of either cisplatin or carboplatin once, every 3 weeks, for 4 doses (total of 12 weeks). Group 3 will get capecitabine treatment for 18 weeks. Participants will take the capecitabine pills twice a day for 2 weeks and then get one week off (called a cycle). There will be six cycles. After finishing treatment, all participants will be followed for about 10 years (every 3 months for the first 2 years from study entry, every 6 months if they are 2-5 years from study entry, every 12 months if they are 5-10 years from study entry).
Some of the eligibility criteria include:

- Participants must have early stage breast cancer.
- Participants must have triple negative breast cancer (ER-, PR- and HER2-).
- 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.
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 MEDI4…
The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 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 inhibiting 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.
Cristofanilli, MassimoCristofanilli, Massimo
NCT02536794 STU00200984
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1-855-NU-STUDY
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x(CIRB) NRG-BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
This randomized phase II/III trial studies how well standard of care therapy with stereotactic…
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
Strauss, Jonathan BStrauss, Jonathan B
NCT02364557 STU00201769
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1-855-NU-STUDY
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(CIRB) ECOG-ACRIN 6134: A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
This randomized phase III t…
This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02224781 STU00201842
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Study Coordinator 312 695 1102
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Genomic Medicine at Northwestern: Discovery and Implementation in the eMERGE Network
We are studying how patients and physicians use and value genetic information that resides in the electronic medical record. We plan to recruit and return information on over 100 genes to 3,000 Northwestern patients…
We are studying how patients and physicians use and value genetic information that resides in the electronic medical record. We plan to recruit and return information on over 100 genes to 3,000 Northwestern patients. Most of the genes being analyzed as part of this study have been linked to the development of a disease or condition, such as certain inherited cancers, certain types of inherited heart-related condition, and how our bodies respond to certain medications. There will also be some genes studied where the usefulness still being determined. Only results determined to potentially affect decisions that you and your physician(s) may make regarding your health care management will be placed in the electronic health record (EHR) for use by you and your Northwestern physicians. To participate, individuals need to be over 18 years of age, see a Northwestern physician, sign a consent form and donate approximately 1 table spoon of blood. Participants will also complete a baseline survey, will be given the option to be interviewed after receiving their results, and the option to participate in the NUgene Project, a genetic biobanking project designed to collect and store genetic and health information and provide those samples to researchers studying the genetics of common conditions such as diabetes, cancer, and heart disease.
Any Northwestern Medicine Patient who is 18 years of age or older.
Smith, Maureen ESmith, Maureen E
STU00201671
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Hoell, Christin Jane 312 695 0700
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Iron Deficiency and FGF23 Regulation in Chronic Kidney Disease and Heart Failure
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iro…
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iron sucrose therapy can safely and successfully lower FGF23 levels. Iron sucrose has been shown to lower FGF23 in animal models. The short term effects of iron sucrose on FGF23 levels in CKD and CHF are not known. We are conducting this research study to understand the effects of intravenous iron sucrose therapy on blood levels of FGF23 in iron deficiency anemia in healthy individuals, individuals with CHF, individuals with CKD, and individuals with CKD and CHF. The information gained from this study could be used to improve the health of patients with iron deficiency anemia and disease of the kidneys and heart.
hemoglobin < 12, ferritin <100 or ferritin <300 w/ TSAT < 20, no active infections, no active use of immunosuppresants
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03106298 STU00201742
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Fox, Patrick 312 503 1887
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NU WU15S01: A Phase II Study of Pazopanib as Front-Line Therapy in Patients with Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy
Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is …
Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is well tolerated with minimal side effects, the investigators propose a phase II study to evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic disease who are not candidates for cytotoxic chemotherapy.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02300545 STU00201925
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Study Coordinator 312 695 1102
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A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)
This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (…
This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment.
Gordon, Leo I IGordon, Leo I I
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02631044 STU00201825
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Study Coordinator 312 695 1102
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SMART Weight Loss Management
SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss…
SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss and best follow-up approach for those who need more support from a weight loss program
You are between the ages of 18 - 60 years old.
You will live in the Chicagoland area for the next 12 months.
You are NOT currently pregnant, trying to become pregnant, or breastfeeding.
You do NOT have an unstable medical condition.
You own an Android or iPhone smartphone.
You are willing to track your lifestyle behaviors using a smartphone for 3 months.
Spring, BonnieSpring, Bonnie
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
NCT02997943 STU00202075
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Scanlan, Laura 312 503 1395
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An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life among Hispanic Women Completing Active Treatment for Breast Cancer
The purpose of this study is to compare 2 health applications designed to address the wellbeing of Hispanic/Latina breast cancer patients. These hea…
The purpose of this study is to compare 2 health applications designed to address the wellbeing of Hispanic/Latina breast cancer patients. These health applications are delivered through a phone and are designed to help address wellbeing after breast cancer treatment. The applications are interactive and include videos, as well as important resources. Participation consists of completing in 1 in-person meeting, using one of the phone applications for 6 weeks on your own time, and completing 2 follow-up phone interviews. // El propósito de este estudio es comparar 2 aplicaciones de salud enfocadas en el bienestar de pacientes hispanas / latinas después del cáncer de seno. Estas aplicaciones de salud se entregan a través de un teléfono y están diseñadas para abordar el bienestar después del tratamiento del cáncer de mama. Las aplicaciones son interactivas e incluyen videos, así como recursos importantes. Participación consiste en completar 1 cita en persona, usar una aplicación de teléfono por 6 semanas, y hacer 2 entrevistas por teléfono después de usar la aplicación.
You may qualify if you: 1) Identify as Hispanic or Latina, 2) are able to read English or Spanish, 3) have been diagnosed with breast cancer and 4) have completed breast cancer treatment no more than 2 years ago (current hormonal treatment and target therapy allowed). //
Usted podría ser elegible si: 1) se identifica como Hispana/Latina 2) puede leer y escribir en inglés o en español 3) ha sido diagnosticada con cáncer de seno y 4) ha completado su tratamiento, no mas de 2 años atrás (el uso actual de terapia hormonal o terapia localizada es permitido).
Yanez, BetinaYanez, Betina
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00201961
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Buitrago, Diana 312 503 2866
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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 15B08: A Phase II Single Arm Study of Palbociclib in Patients with Metastatic HER2-positive Breast Cancer with Brain Metastasis
Purpose The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to d…
Purpose The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to determine the overall radiographic response rate in the CNS. Overview Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as triple negative and HER2 positive breast cancer. The study drug palbociclib is a small molecule and can penetrate the meninges. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have triple negative and HER2-positive breast cancer. Description of Treatment All study participants will get the study drug in the form of a pill that will be taken once a day for 21 days followed by a 7 day break. These 28 days is considered as one cycle. The participants with HER2-positive breast cancer may also receive trastuzumab (standard of care) concurrently.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02774681 STU00202582
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Study Coordinator 312 695 1102
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Alliance A091305: A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination with Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer
This randomized phase II trial studies how well efatutazone with paclitaxel compared to paclitaxel alone works in treating patie…
This randomized phase II trial studies how well efatutazone with paclitaxel compared to paclitaxel alone works in treating patients with advanced anaplastic thyroid cancer. Drugs used in chemotherapy, such as efatutazone 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 efatutazone in combination with paclitaxel is more effective than paclitaxel alone in treating patients with advanced anaplastic thyroid cancer.
Matsangou, MariaMatsangou, Maria
NCT02152137 STU00202641
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1-855-NU-STUDY
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(xIRB) NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
This randomized phase III trial …
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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 doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02488967 STU00203129
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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 vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bi…
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Participants must be 18 years or older and have a meningioma which has gotten bigger or grew back after treatment.
Kumthekar, PriyaKumthekar, Priya
NCT02523014 STU00202953
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NU 16I01: Phase I/Ib study of nivolumab in combination with Therasphere (yttrium-90) in patients with advanced hepatocellular carcinoma.
Purpose The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unaccept…
Purpose The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unacceptable side effects, for combination treatment of nivolumab and Y-90. Also, to evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere). Overview Nivolumab is currently FDA approved for other cancers, but has not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Y-90 is currently FDA approved for the treatment of hepatocellular carcinomas, but has not yet been investigated in combination with nivolumab for this disease. This is a phase I study of 2 drugs used in combination: nivolumab and Y-90. We think the combination of these drugs may be more effective against your cancer. Description of Treatment All study participants will get the same study intervention. All study participants will get the study drug Nivolumab. You will receive induction treatment with Y-90, and then approximately four weeks after, you will receive Nivolumab once every 2 weeks (given through the vein over 30 minutes). After you finish your treatment with nivolumab, the study team will continue to watch you for side effects for up to 30 days from your last treatment. If you discontinue from the study for any reason, the study team will continue to check how you are doing every 2 weeks for up to 24 weeks from the start of your treatment.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kalyan, AparnaKalyan, Aparna
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02837029 STU00203003
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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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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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Lipiszko, Olga 312 503 6568
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AHA Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health-Study 2
NUYou is a two year cardiovascular health study using a mobile app.
The study is closed to recruiting. To test whether a health intervention in the form of a mobile phone
application will preserve or improve heart healthy behaviors (nonsmoking, healthy diet, physical
activity, healthy weight) and cardiovascular health biomarkers (blood pressure, and fasting
cholesterol and glucose) in college students between their freshman and junior year.
Spring, BonnieSpring, Bonnie
STU00202845
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Hood, Susan 312 503 0945
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A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Purpose This is a Phase III study to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS) Overview This study will allow the researchers to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy Description of Treatment This study has two study groups. Group 1 will receive a placebo in the form of a tablet that looks like the study drug but contains no medication, and Group 2 will receive the study drug olaparib in the form of a tablet. A computer will by chance assign patients to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other.
Some of the eligibility criteria include:

- Female or Male participants must be 18 years of age or older.

a) For patients who underwent initial surgery and received adjuvant chemotherapy

-TNBC patients must have been axillary node-positive (>/= pN1, any tumor

size) or axillary node negative (pN0) with invasive primary tumor

pathological size > 2 cm (>/= pT2).

-ER and/or PgR positive/HER 2 negative patients must have had >/= 4 pathologically confirmed positive lymph nodes.

b) For patients who underwent neoadjuvant chemotherapy followed by surgery

-TNBC patients must have residual invasive breast cancer in the breast and/or

resected lymph nodes (non-pCR)

-ER and/or PgR positive/HER2 negative patients must have residual invasive

cancer in the breast and/or the resected lymph nodes (non-pCR) AND a CPS&EG score >/= 3.

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.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02032823 STU00203491
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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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Study Coordinator 312 695 1102
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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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Study Coordinator 312 695 1102
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NU 16C01: A Phase 0 first-in-human study using NU-0129: a spherical nucleic acid (SNA) gold nanoparticle targeting BCL2L12 in recurrent glioblastoma multiforme or gliosarcoma patients
Purpose The purpose of this research study is to evaluate the safety of NU-0129 SNA gold nanoparticle infusion in …
Purpose The purpose of this research study is to evaluate the safety of NU-0129 SNA gold nanoparticle infusion in patients with recurrent glioblastoma multiforme or gliosarcoma Overview This is a first-in-human trial to determine the safety of NU-0129. The study drug is composed of a small gold nanoparticle that has spherical nucleic acid attached to it. This small particle allows NU-0129 to cross the blood brain barrier (a filtering mechanism that carry blood to the brain). Once within the tumor, the nucleic acid component is able to target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of programmed cell death, thus promoting tumor growth. Researchers think that targeting the Bcl2L12 gene with NU-0129 will help stop cancer cells from growing. Description of Treatment All study participants will receive the same study drug, NU-0129, given through vein one time over 20 minutes as an inpatient. Within two days of getting this drug, participants will have a tumor resection surgery, recommended by their doctor. The study team will continue to watch for any side effects for at least 4 weeks with clinic visits and lab tests done each week. The study team will also continue to check how the subjects are doing with a clinic visit at least every 3 months for up to 2 years or until their disease comes back.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03020017 STU00203790
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Study Coordinator 312 695 1102
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NU 16H07: Phase II Trial of Pembrolizumab in Combination with ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regim…
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called “ICE” and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently FDA approved for the treatment of melanoma, but has not yet been investigated in Relapsed/Refractory Hodgkin Lymphoma. The ‘ICE’ regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. This is a phase II study of these drugs used in combination. For patients who have a relapse of their Hodgkin’s lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure. Research continues to find for the best regimen to obtain a complete remission in this setting.
Some of the eligibility criteria include:
• Patients must have a histologically confirmed diagnosis of classical Hodgkin lymphoma.
• Patients must have relapsed/refractory disease, with at least one line of prior chemotherapy, but not more than 2 prior lines of treatment, for Hodgkin lymphoma.
• Patients must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03077828 STU00203658
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Study Coordinator 312 695 1102
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Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas.
Purpose The purpose of this study is to compare the effects (good and bad) of the study drugs temozolomide and cap…
Purpose The purpose of this study is to compare the effects (good and bad) of the study drugs temozolomide and capecitabine to cisplatin and etoposide, the drugs used for usual chemotherapy treatment for advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas. Overview Cisplatin and etoposide is usually the first treatment given for neuroendocrine cancer. The chemotherapy drugs temozolomide and capecitabine may be used are also used to treat this disease but usually not until the first treatment, cisplatin and etoposide, stops working. It is not known if this is the best approach or if the temozolomide and capecitabine should be given first instead. Researchers are trying to determine if one chemotherapy combination is better than another for neuroendocrine cancers. Description of Treatment Study participants will be randomly assigned by chance (like the flip of a coin) to one of the two study groups. Group 1 will receive the study drugs temozolomide and capecitabine. Group 2 will receive the usual approach for this cancer; cisplatin and etoposide. Study visits will be grouped into cycles. The number of cycles of study treatment depends on how well each participant is tolerating treatment and how well the cancer responds to it. Group 1 will take the study drug capecitabine by mouth twice a day for 14 days in a row. During the last five days of the 14 days of taking capecitabine, participants will take temozolomide by mouth once a day as well. After the 14 days of treatment participants will have 14 days off from treatment before any further treatment is started. This 28-day period is one cycle for Group 1. Group 2 will receive cisplatin and etoposide through a vein. This treatment will be given at a clinic visit once a day for three days in a row, and then participants will have 18 days off before any further treatment is received. This 21-day period is one cycle for Group 2.
Some of the eligibility criteria include:

- Participants must have a locally advanced and unresectable or metastatic gastroenteropancreatic G3 neuroendocrine carcinoma of the GI tract.
- Participants must have pathologically/histologically confirmed tumor of non-small cell histology.
- Participants must be at least 18 years of age

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.
Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02595424 STU00204209
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Study Coordinator 312 695 1102
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A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. T…
EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. These agents often have a side effect of an acne like rash that in some cases can be quite severe. This rash has been shown to be inflammatory in origin but is currently treated with antibiotics if it appears. The main goal of this study is to test if patients treated with steroid cream, (added) which is an anti-inflammatory medication, (added) before a rash develops have a less severe rash than patients who do not use a steroid cream before a rash develops.
Must be 18 years of age or older with a diagnosis of cancer and starting an (changed from 'and') EGFR inhibitor. During the study you must be willing to fill out a daily diary, use sunscreen and cream daily, and fill out 2 questionnaires and have photographs taken every 2 weeks for 4 visits.
Choi, JenniferChoi, Jennifer
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03115567 STU00203631
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Kosche, Cory 312 503 5944
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Phase II study of nivolumab and ipilimumab for treatment of advanced adenoid cystic carcinoma and non-adenoid cystic carcinoma
Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combinati…
Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combination in participants with this type of cancer. Another purpose of the study is to see which tumor markers (proteins in the blood that the body produces in response to the cancer) lead to better results in participants treated with the study drugs. Overview Nivolumab and ipilimumab are antibodies, which are human proteins that recognize and attach to a part of the tumor and/or body‰Ûªs immune cells. They work in slightly different ways to activate the immune system and help the body‰Ûªs immune system to work against tumor cells. The combination of these drugs is already approved by the FDA to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are investigational because they are not approved by the FDA to be used for the type of cancer being studied. Description of Treatment All study participants will receive the same study drugs, nivolumab/ipilimumab combination, over periods called cycles (1 cycle = 12 weeks / 84 days). Nivolumab will be given through a vein over 30 minutes once every 2 weeks for the first 16 weeks. It will then be given over 60 minutes once every 4 weeks for as long as participants are benefitting. Ipilimumab will be given through a vein over 90 minutes every 6 weeks (twice each cycle). Participants will take part in the study as long as they are benefitting from the study drugs.
Some of the eligibility criteria include:

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

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Dinner, ShiraDinner, Shira
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02752035 STU00203834
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Study Coordinator 312 695 1102
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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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312 695 8146
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METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (the study device) in part…
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (the study device) in participants with brain metastases (tumors) as a result of non-small cell lung cancer (NSCLC). This study will test the efficacy, safety and neurocognitive outcomes of advanced NSCLC participants, following stereotactic radiosurgery (SRS) for brain metastases, treated with NovoTTF-100M and supportive treatment when compared to being treated with supportive treatment alone. This is a research study to test a study device, NovoTTF-100M, which is an investigational device and has not been approved by the FDA to treat this type of cancer and therefore is being considered investigational. This study has two study groups. Participants will be randomly placed into one of the two following groups; Supportive care only group OR NovoTTF-100M group.
Participants must be 18 years of age or older. Participants who have non-small cell lung cancer that has spread to the brain (brain metastases).
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02831959 STU00204448
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Study Coordinator 312 695 1102
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Development of an eHealth-based Cognitive Behavioral Stress and Self-Management Intervention to Reduce Symptom Burden in HIV+ Gay and Bisexual Men and Trans Women Treated for Non-Metastatic Cancer
This pilot study aims to adapt a web-based program for HIV+ cancer survivors. Eligible patients may part…
This pilot study aims to adapt a web-based program for HIV+ cancer survivors. Eligible patients may participant in one of the following phases: Phase I, which will include one focus group or interview about patients' experiences co-managing cancer and HIV; Phase III, which will involve one usability session where patients test out an early version of the "SmartManage" website; or Phase IV, which will consist of a 6-week field trial completed from home. Eligible clinicians may enroll in Phase II of the pilot, which will involve one interview with study staff, in which clinicians speak about their experiences treating this patient population.
Patient/participants must:1) Identify as gay or bisexual men or trans women, 2) be HIV+, and 3) have been diagnosed with non-metastatic cancer. Clinician/participants must treat patients in this general population.
Penedo, Frank JPenedo, Frank J
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00204925
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Thomas, Jessica 312 503 7724
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A PHASE I STUDY OF NEURAL STEM CELL BASED VIROTHERAPY IN COMBINATION WITH STANDARD RADIATION AND CHEMOTHERAPY FOR MALIGNANT GLIOMA
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Bas…
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diganosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.
Inclusion Criteria:
•Patients must have presumed malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of stereotactic biopsy or resection prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
•Tumor must be accessible for injection and must not be located in the brainstem, or contained within the ventricular system.
•Planning to undergo standard radiation/chemotherapy
•18 years of age or older.
•Performance status must be KPS ≥ 70
•SGOT (AST) < 3x upper limit of normal
•Serum creatinine < 2mg/dl
•Platelets > 100,000/mm3 and WBC > 3000/mm3

Exclusion Criteria:
•Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection.
•Immunosuppressive drugs (with exception of corticosteroid).
•Known HIV+ patients.
•Acute infections (viral, bacterial or fungal infections requiring therapy).
•Pregnant or breast-feeding patients.
•Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
•Prior radiation therapy to the brain or prior treatment for brain tumor Other serious co-morbid illness or compromised organ function
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03072134 STU00203933
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Amidei, Christina 312 695 9124
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Alliance A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study Of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue In Patients With High Grade Glioma
The purpose of this study is to: • See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve …
The purpose of this study is to: • See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue. • See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.
Participants must be 18 years of age or older and experiencing fatigue that is related to their cancer.
Dixit, KaranDixit, Karan
NCT01781468 STU00204894
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1-888-NU-STUDY
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NCI 2015-06-04 Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
Khan, Seema AhsanKhan, Seema Ahsan
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02993159 STU00204804
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Xu, Yanfei 1 312 472 0595
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BTCRC GYN15-013: Phase II Study of Pembrolizumab in Combination with Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and ca…
The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and carboplatin chemotherapy.
Participants will be adults with cancer in the lining of the uterus (endometrium) that has spread to other parts of the body or has returned after initial treatment.
Matei, DanielaMatei, Daniela
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02549209 STU00204968
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Study Coordinator 312 695 1102
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NCI 2015-06-03 Statin Therapy to Reduce Disease Progression from Liver Cirrhosis to Cancer
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg d…
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg daily or placebo daily, a pill that looks like simvastatin 40 mg but contains no medication. Simvastatin is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk for heart attack, stroke, and chest pain in patients who have heart disease or risk factors for heart disease such as smoking, high blood pressure, low high-density lipoprotein (HDL), or family history of early heart disease. It is also approved to lower the risk for heart attack or stroke in patients with type 2 diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure. However, simvastatin is not approved by the FDA to decrease the risk of liver cancer. Simvastatin is considered “investigational” (a study drug) in this study. Studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. We believe that this anti-inflammatory effect of simvastatin may help patients with liver cirrhosis.
Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Leukocytes >= 2,500/microliter
Absolute neutrophil count >= 1,500/microliter
Platelets >= 50,000/microliter
Hemoglobin >= 10 g/dL
Total bilirubin =< 3 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN
Creatinine =< 1.5 x institutional ULN
Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
Women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Ability to understand and the willingness to sign a written informed consent document and medical release
Willing and able to comply with trial protocol and follow-up
Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 7 months
Kulik, Laura MKulik, Laura M
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02968810 STU00204992
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Sipich, Kimberly A 312 694 1293
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(xIRB NCI CIRB) SWOG 1609 DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Purpose The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. Overview…
Purpose The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. Overview The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-quarter compared to its present size. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin. Description of Treatment All study participants will get the same study drugs: ipilimumab and nivolumab. Participants will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and they will receive nivolumab through a vein every 2 weeks. Participants will continue to receive study drugs until their disease gets worse or they experience bad side effects from the study drugs or their study doctor decides that they are not benefiting from the study drugs.
Some of the eligibility criteria include:

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

No other prior malignancy is allowed except for the following:

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

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02834013 STU00205572
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Study Coordinator 1 312 695 1102
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NU 16H08: Phase II study of PET-directed frontline therapy with pembrolizumab and AVD for patients with classical Hodgkin lymphoma
The purpose of this research study is to evaluate a new drug, pembrolizumab, followed by chemotherapy, for the treatment of newly diagnosed classical Hodgkin lymphoma. Th…
The purpose of this research study is to evaluate a new drug, pembrolizumab, followed by chemotherapy, for the treatment of newly diagnosed classical Hodgkin lymphoma. The chemotherapy regimen is called “AVD” and includes three drugs: doxorubicin, vinblastine, dacarbazine. Pembrolizumab is currently FDA approved for the treatment of relapsed Hodgkin lymphoma, but is not approved for use in newly diagnosed patients. The ‘ABVD’ regimen of chemotherapy is the standard of care for the treatment of newly diagnosed classical Hodgkin lymphoma. Not all patients achieve a complete remission with ABVD, and older patients tolerate the regimen poorly. Patients who do not have a complete response to standard ABVD chemotherapy (meaning there is still evidence of disease on PET scans performed at the end of treatment), may be treated with radiation or a more intensive chemotherapy regimen. Patients who don’t achieve a complete remission with frontline treatment (refractory disease) or those who relapse require treatment with high dose chemotherapy and a stem cell transplant. Older patients, however, are not candidates for intensive chemotherapy or stem cell transplant. This is a phase II study of pembrolizumab followed by AVD (ABVD without bleomycin) for patients with newly diagnosed classical Hodgkin lymphoma. Some older patients may receive an additional one to two years of pembrolizumab maintenance.
Some of the eligibility criteria include:
• Patients must have a confirmed diagnosis of classical Hodgkin lymphoma.
• Patients must have previously untreated disease
• Patients must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03226249 STU00203707
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Study Coordinator 312 695 1102
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MY PATHWAY: AN OPEN-LABEL PHASE IIA STUDY EVALUATING TRASTUZUMAB/PERTUZUMAB, ERLOTINIB, VEMURAFENIB/COBIMETINIB, VISMODEGIB, ALECTINIB, AND ATEZOLIZUMAB IN PATIENTS WHO HAVE ADVANCED SOLID TUMORS WITH MUTATIONS OR GENE EXPRESSION ABNORMALITIES PREDICTIVE OF RESPONSE TO ONE OF THESE AGENTS
Trastuzumab…
Trastuzumab/Pertuzumab combination, Erlotinib, Vemurafenib/Cobimetinib combination, Vismodegib, Alectinib and Atezolizumab are agents that target specific proteins that cause or contribute to the growth and spread of cancers. These targeted therapy agents have been tested and approved by the US FDA to treat some types of cancer but not others. The purpose of this research study is to evaluate whether these targeted drugs is safe and effective for the treatment of other types of cancers. Many cancers contain molecular abnormalities that cause or contribute to their ability to grow and spread. These molecular and genetic changes can be detected in the laboratory tests. By blocking the effects of these abnormalities, the growth of cancer may be stopped or slowed down. Many new cancer drugs work in this way. Because they block the effects of specific molecular abnormalities within the cancer, they are known as “targeted” agents. Patients are now able to have molecular tests done on their tumor tissue (“molecular profiling”), in order to identify potential molecular abnormalities that may be treated with targeted drugs. Some of these targeted drugs have been approved by the US FDA to treat certain types of cancer but not others. The purpose of this study is to evaluate if these targeted drugs is safe and effective for the treatment of other types of cancers.
Some of the eligibility criteria include:1) Molecular testing results from a certified lab showing an abnormality that can be targeted with any of the above agents; 2) Able to understand the nature of this trial and provide written informed consent; 3) Participants must be 18 or older.
Villaflor, VictoriaVillaflor, Victoria
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02091141 STU00205235
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Study Coordinator 312 695 1102
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DRUG CA209-816: Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the …
The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the drug works) of nivolumab in combination with ipilimumab and nivolumab in combination with plantinum doublet chemotherapy in subjects with non-small cell lung cancer.
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02998528 STU00205030
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Study Coordinator 312 695 1102
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NU UW16B13: A Phase II Study of Neratinib Alone and in Combination with Fulvestrant in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
Certain types of breast cancer test positive for overexpression HER2 (a protein involved in normal cell growth) and some test negative. Some patients may …
Certain types of breast cancer test positive for overexpression HER2 (a protein involved in normal cell growth) and some test negative. Some patients may have HER2-negative breast cancer with mutations in HER2. Neratinib is an investigational drug - meaning that it has not been approved by the U.S. Food and Drug Administration [FDA] - shown to be effective for treating HER2-positive breast cancer in clinical trials. An additional routine treatment involves a drug called Fulvestrant, which blocks the effects of estrogen in breast tissue. In this study, the uses of neratinib alone or in combination with Fulvestrant, will be studied, to see how the cancer responds to these treatments in each population.
Diagnosis with metastatic breast cancer at the time of screening
Diagnosis of metastatic breast cancer that is HER2-negative, but found to have a mutation in HER2 at the time of enrollment
Age of at least 18 years
Completion of radiation therapy and be at least 1 week from the last administration before starting study treatment
Cristofanilli, MassimoCristofanilli, Massimo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01670877 STU00205349
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Study Coordinator 312 695 1102
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Clinical Database of Nephrectomy at Northwestern University
The goal of this study is to determine the current clinical outcomes of our nephrectomy patients at Northwestern (such as complications and survival). We hope to keep track of patients for the first 5-years following radical or partial nep…
The goal of this study is to determine the current clinical outcomes of our nephrectomy patients at Northwestern (such as complications and survival). We hope to keep track of patients for the first 5-years following radical or partial nephrectomy in order to better understand the long-term behavior of the disease.
Patients ages 18-89 with a diagnosis of kidney cancer.
Nadler, Robert BNadler, Robert B
STU00205973
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312 695 6124
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(xIRB NCI-CIRB) SWOG 1512: A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unsectable Desmoplastic Melanoma (DM)
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembr…
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembrolizumab) could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will cause the cancer to at least temporarily disappear in more than twenty percent of patients with melanoma that is not surgically removable. In patients with melanoma that is surgically removable, researchers also hope to learn if the study drug will cause the surgery to be more effective and avoid repeated surgery.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02775851 STU00205551
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Study Coordinator 312 695 1102
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A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent"
The purpose of this study is to compare any good and bad effects of using ipilimumab in combination with nivolumab to th…
The purpose of this study is to compare any good and bad effects of using ipilimumab in combination with nivolumab to the usual approach of using ipilimumab alone when treating melanoma that cannot be removed by surgery. The combination treatment of ipilimumab and nivolumab could stop a participant's melanoma from getting worse, 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. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating melanoma. This study has two treatment groups, Group 1 and Group 2. Participants in Group 1 will receive ipilimumab once every three weeks for up to four times. Participants in Group 2 will receive nivolumab and ipilimumab once every three weeks for up to four times.
Participants must be at least 18 years of age. Participants must have melanoma that cannot be removed by surgery. Participants have received an immunotherapy drug (a drug that helps the body’s immune system destroy cancer cells), and their cancer got worse while receiving that.
Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03033576 STU00205856
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Study Coordinator 312 695 1102
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A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
This research study is investigating a drug (that is called IMCgp100) in patients with a…
This research study is investigating a drug (that is called IMCgp100) in patients with advanced uveal melanoma. Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the immune system, known as immunotherapies. In this research study, IMCgp100 will be compared to three representative standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug targeting a protein called CTLA-4), or pembrolizumab (an immunotherapy drug targeting a protein called PD-1). This research study is being done to assess the efficacy and safety of the IMCgp100 in patients with uveal melanoma in comparison to these standard treatments.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000418 STU00205550
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Study Coordinator 312 695 1102
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(xIRB) A Phase 1 Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients with Selected Relapsed/Refractory Hematological Malignancies

Somehematologic cancer cells make a protein called ASCT2 (Na+ dependentalanine-serine-cysteinetransporter 2).  MEDI7247 is a drug madeof two parts: one part is a protein known as an antibody that can grab ontoASCT2 and the second part is a chemotherapy drug that is linked to the antibodyand is expected to kill cancer cells. The way that MEDI7247 is thought to work is that once it is in thebloodstream and has reached the tumor, the antibody part of MEDI7247 is expected to attach to ASCT2 proteins onthe outside of a cancer cell; then, MEDI7247 is supposed to be pulled insidethe cell. Once inside the cancer cell, the chemotherapy drug is released fromthe antibody and is expected to kill the cancer cell.  In lab studies, MEDI7247 can kill cancercells that make a lot of ASCT2 protein.


The purpose of this study isto see if MEDI7247 is safe and well tolerated, to learn what kind of sideeffects it can cause, to measure how long MEDI7247 stays in the bloodstream(pharmacokinetics), to learn how much MEDI7247 (what dose level) should begiven in future studies, and to test whether MEDI7247 can shrink cancers thatmake different amounts of the ASCT2 protein.

Some ofthe eligibility criteria include:

  • Relapsed (the signs or symptoms of your disease return after standard therapy), /Refractory (cancer does not respond to therapy or is resistant to the therapy) of one of the three conditions:
    • Acute Myeloid Leukemia
    • Multiple Myeloma
    • Diffuse Large B-Cell Lymphoma
  • 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 NorthwesternUniversity for complete screening information if you are interested in thisclinical trial.
Karmali, ReemKarmali, Reem
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03106428 STU00205485
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Study Coordinator 1-888-NU-STUDY
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DRUG CO39722: A PHASE III, OPEN-LABEL, MULTICENTER, TWO-ARM, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF COBIMETINIB PLUS ATEZOLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED BRAFV600 WILD-TYPE MELANOMA.
The purpose of this study is to compare the efficacy a…
The purpose of this study is to compare the efficacy and safety of cobimetinib plus atezolizumab with the efficacy and safety of pembrolizumab in patients with a type of skin cancer called melanoma that has spread to other parts of the body (metastatic), cannot be removed by surgery (unresectable), and have not received any prior treatment.
Clinically confirmed Stage melanoma or unresectable Stage 3 melanoma, age 18 years or older
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000419 STU00205830
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Study Coordinator 312 695 1102
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Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the inter…
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous) through a vein. About 12 people are expected to participate in this research study here at Northwestern University out of 160 people in the entire study nationally.
Some of the eligibility criteria include:
• Participants must be 18 or older.
• Patient must have the ability to understand and sign an approved informed consent form (ICF).
• Patient must have a confirmed diagnosis of advanced Renal Cell Carcinoma (RCC).
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Sosman, JeffreySosman, Jeffrey
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03117309 STU00205969
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Study Coordinator 312 695 1102
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Clinical Database of Prostate Cancer at Northwestern University
The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
Men ages 18-89 years daignosed with prostate cancer.
Schaeffer, EdwardSchaeffer, Edward
STU00206270
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Khawaja, Faizan 312 694 2417
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DRUG 2215-CL-9100A Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients with FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) with Minimal Residual Disease (MRD)
This is an open lab…
This is an open label study (both the participant and your study doctor will know what study drug the participant takes) research study for patients who have FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML), or FLT3-Mutated AML in Complete Remission with Minimal Residual Disease (MRD).The purpose of the study is to test safety and expand access to a drug called gilteritinib (ASP2215) when access to a comparable or alternative therapy is not available. Gilteritinib (ASP2215) is an experimental drug that is being studied to treat AML. It is being tested in clinical trials and has not been approved by U.S. Food and Drug Administration (FDA) and/or any other regulatory authorities for any indication. Participants will have a screening visit up to 2 weeks before the start of treatment. Participants will be given treatment over 28-day cycles. Participants will be asked to take the study medications one a day by mouth. Participants will be asked to come to the clinic for visits on cycle 1 days 1, 4, 8, 15; cycle 2 days 1 and 15; and day 1 of each cycle after until participants have been discontinued from the study.
Participants must be at least 18 years of age or older and have a diagnosis of primary AML or AML secondary to MDS or therapy-related
AML.
Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03070093 STU00205817
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Study Coordinator 312 695 1102
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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, EdwardSchaeffer, Edward
NCT03392181 STU00205957
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Khawaja, Faizan 312 694 2417
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A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogeneic stem cell transplantation (REACH 3)
The purpose of the study is to find out if the drug ruxolitinib is safe and prov…
The purpose of the study is to find out if the drug ruxolitinib is safe and provides better treatment in comparison with “Best Available Therapy” in people who have chronic (does not get better over time) Graft-versus-Host-Disease that does not get better with steroid medications
Currently on steroids for GVHD post Allogenic Stem Cell Transplant.
Choi, JenniferChoi, Jennifer
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03112603 STU00206339
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Kosche, Cory 312 503 5944
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(xIRB NCI) SWOG 1605: Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
The purpose of this study is to test the good and bad effects of the investigational drug atezolizumab in stopping non-muscle invasive bladder cancer from coming back and progressing to muscle …
The purpose of this study is to test the good and bad effects of the investigational drug atezolizumab in stopping non-muscle invasive bladder cancer from coming back and progressing to muscle invasive bladder cancer. Atezolizumab is not approved by the FDA for treatment of this type of cancer. Atezolizumab is a type of immunotherapy (a drug that helps your body to fight a specific part of each cancer cell).
• Participants must be 18 years or older
• Participants must have superficial bladder cancer that has not invaded into the bladder muscle wall and did not respond to BCG.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02844816 STU00206426
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Study Coordinator 1-888-NU-STUDY
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AN OPEN-LABEL, PHASE 2 STUDY OF NERATINIB IN PATIENTS WITH SOLID TUMORS WITH SOMATIC HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR, HER2, HER3) MUTATIONS OR EGFR GENE AMPLIFICATION

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

 

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

 

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

Some of the eligibility criteria include:

  • Participants must be 18 or older.
  • Patient must have the ability to understand and sign an approved informed consent form (ICF).
  • Patient must have a confirmed diagnosis of cancers with mutations in ERBB family
Note: This is only apartial list of eligibility criteria. Please contact the Robert H. Lurie ComprehensiveCancer Center of Northwestern University for complete screening information ifyou are interested in this clinical trial.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT01953926 STU00206494
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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 2, Open-Label, 2-Cohort Study of INCB050465, a PI3K Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
INCB050465 is an investigational drug that is being developed by Incyte Corporation (the “Sponsor” …
INCB050465 is an investigational drug that is being developed by Incyte Corporation (the “Sponsor” of the research Study) for use in the treatment of marginal zone lymphoma. “Investigational” means that INCB050465 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. At Northwestern University, about 10 people are expected to be enrolled in this research study out of 120 people in the entire study internationally. The primary purpose of this Study is to determine what effect the Study Drug has on your disease. This Study will also evaluate the safety the Study Drug is and how much of the Study Drug is present in your blood at different time points. If you qualify for the study, you will be enrolled in a group based on the prior treatment you received for your cancer. Your Study Doctor will tell you which group you will be assigned to. This Study will evaluate two different dosing regimens of the Study Drug.
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 Marginal Zone Lymphoma.
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.
Ma, ShuoMa, Shuo
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03144674 STU00206395
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Phase Ib, open label, combination study of nintedanib with 5- azacitidine in acute myeloid leukemia characterized by HOX gene overexpression, that are not candidates of intensive chemotherapy
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with aza…
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant’s response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant’s leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.
Newly diagnosed and relapsed/refractory acute myeloid leukemia characterized by HOX gene overexpression. Patients should be ≥18 years. Patients who are not eligible for, or decline intensive chemotherapy.
Altman, Jessica KAltman, Jessica K
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206525
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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 aninvestigational drug, called VRx-3996, along with an antiviral (fights viruses)drug called valganciclovir. VRx-3996 is an investigational drug that is beingdeveloped by Viracta Therapeutics, Inc. (the “Sponsor” of the research Study)for use in the treatment of a specific type of lymphoma known as Epstein-BarrVirus (EBV+)-Associated Lymphomoid malignancies. Treatment with VRx-3996 isintended to induce expression of certain viral genes that are normally dormantin EBV-associated cancers, induction of which renders the virus and dividing(i.e. cancerous) cells that harbor the virus, susceptible to eradication bycombination treatment with valganciclovir.  “Investigational” means that VRx-3996 has notbeen approved by the United States Food and Drug Administration (FDA) for useas a prescription or over-the-counter medication to treat a certaincondition.  The antiviral drug,valganciclovir has been FDA-approved to prevent and treat certain types ofviral infections. Some people may already have received or are currently takingthe antiviral drug, valganciclovir, for their disease.

 

The primary purposeof this Study is to determine how safe is it to take the VRx-3996 along withvalgaciclovir and find the maximal dose that can be taken safely. The studywill also determine if the cancer responds to treatment with the drugcombination. The study will also evaluate how much of the study drug is presentin your blood at different time points.

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 EBV+ lymphoid malignancy.
Note: This is only apartial list of eligibility criteria. Please contact the Robert H. Lurie ComprehensiveCancer Center of Northwestern University for complete screening information ifyou are interested in this clinical trial.
Karmali, ReemKarmali, Reem
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03397706 STU00206699
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Next-Generation sequencing of cell-free circulating tumor DNA in locally invasive bladder cancer
bloodstream. These pieces are called cell-free circulating tumor DNA (cfDNA). Recent studies in lung and breast cancers have shown that cfDNA can be screened for certain mutations to detect and follow t…
bloodstream. These pieces are called cell-free circulating tumor DNA (cfDNA). Recent studies in lung and breast cancers have shown that cfDNA can be screened for certain mutations to detect and follow the growth of a patient’s tumor. This study aims to apply this technique to bladder cancer and to identify specific mutations unique to varying stages of bladder cancer. This technology has been applied to other cancers but has not yet been studied in bladder cancer. We plan to determine whether this technology is able to identify genetic mutations linked to bladder cancer.
Patients age 18-89 years old with early invasive (T1) and muscle invasive (T2+) bladder cancer .
Meeks, Joshua JMeeks, Joshua J
STU00206645
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312 695 8146
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A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA (Protocol #RD.03.SPR.104003)
This study is being done to …
This study is being done to assess the efficacy and safety of two concentrations of Resuiqimod gel in the treatment of CTCL (stage IA, IB, IIA). In addition, this study will test the systemic effect of Resiquimod gel on lesions distant from the treatment areas.
Must be 18 years or older with a clinical diagnosis of Cutaneous T Cell Lymphoma with at least three distinct lesions, including one distant lesion.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03292406 STU00206325
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Lipiszko, Olga 312 503 6568
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(xIRB) DRUG CPDR001XUS01: Modular phase 2 study to link combination immune-therapy to patients with advanced solid and hematologic malignancies Module 9: PDR001 plus LAG525 for patients with advanced solid and hematologic malignancies

Thedrugs being tested in this study are called PDR001 and LAG525. PDR001 acts by blocking a protein called PD-1and LAG525 acts by blocking a protein called LAG-3. Blocking of these proteins may lead to anincreased ability of the immune system to fight tumor cells.  An experimental or investigational drug meansit has not been approved by the US Food and Drug Administration (US FDA) forthese indications.

 

PDR001 is an antibody. It connectsand blocks a protein called PD-1 which is present on cells calledT-lymphocytes, which are involved in the immune response. By blocking PD-1,PDR001 may increase the activity of T-lymphocytes which may reduce the growthof your tumor. Clinical data with other antibodies blocking PD-1 have shownthat blocking PD-1 may result in reduced tumor cell growth in a variety ofsolid tumors. Results of studies in cancer models in animals have shown thatPDR001 can slow the growth of various types of cancer.

 

LAG525 is an antibody. An antibody is a kind of protein that cells in your bodycan make and it is used in the immune system to recognize and bind to aspecific “target.” LAG525 connects with and blocks the function of a proteincalled LAG-3 which is present on different cell types in the immune system. Byblocking LAG-3, LAG525 may increase the activity of lymphocytes. This effectcould lead to a reduction in your tumor but also to immune type effects or sideeffects similar to the symptoms of autoimmune findings. Autoimmune findings aregenerally associated with inflammation in various parts of the body such as thelung, liver or colon (bowels).

 

The purpose of this study is to find out whateffects, good and/or bad, the combination of PDR001 and LAG525 have withvarious types of cancer.

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 various types of cancer
Note: This is only apartial list of eligibility criteria. Please contact the Robert H. Lurie ComprehensiveCancer Center of Northwestern University for complete screening information ifyou are interested in this clinical trial.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03365791 STU00207231
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A Phase 1/2a, Multicenter, Open Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer

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

 

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

Some of the eligibility criteria include:

  • Participants must be 18 or older.
  • Patient must have the ability to understand and sign an approved informed consent form (ICF).
  • Patient must locally advanced or metastatic cancer.
Note: This is only apartial list of eligibility criteria. Please contact the Robert H. Lurie ComprehensiveCancer Center of Northwestern University for complete screening information ifyou are interested in this clinical trial.
Mahalingam, DevalingamMahalingam, Devalingam
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT02929862 STU00206768
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(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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Partial Wave Spectroscopy for Urine Cytology Analysis
Bladder cancer is the fourth most common in men and sixth overall and while approximately 75% of patients will be diagnosed with superficial cancer, there is a high rate of recurrence. Currently, diagnosis and surveillance require invasive testing…
Bladder cancer is the fourth most common in men and sixth overall and while approximately 75% of patients will be diagnosed with superficial cancer, there is a high rate of recurrence. Currently, diagnosis and surveillance require invasive testing – cystoscopy (using a scope to look inside the bladder). While urine tests are used as part of the workup and follow-up, the current urine tests are limited. Our goal is to test a new technique that looks at individual cells to see if we can improve cancer detection. Cells that line the bladder are frequently shed into the urine, and therefore, these can be studied simply by providing a urine sample and without an invasive test. Our hope is that this urine test will be able to improve initial diagnosis and follow-up for patients with bladder cancer This is an investigational technique and is not approved by the USFDA.
Patients age 18-89 with a confirmed pathologic diagnosis of urothelial carcinoma of the bladder.
Meeks, Joshua JMeeks, Joshua J
STU00206508
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Meeks, Joshua J 312 695 8146
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ATLAS: A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
The investigational drug being investigated in this study is called rucaparib (also known as CO-338 or Rubraca). Rucaparib is approved (trade name: Rubraca) in the US as treatment for …
The investigational drug being investigated in this study is called rucaparib (also known as CO-338 or Rubraca). Rucaparib is approved (trade name: Rubraca) in the US as treatment for patients with advanced ovarian cancer who have been treated with two or more chemotherapies and who have a certain type of abnormal BRCA gene. However, Rucaparib is not approved by the U.S. Food and Drug Administration (FDA) for use in people with urothelial carcinoma, which is why its use in this study is INVESTIGATIONAL and still being tested.


Rucaparib belongs to a class of anti-cancer agents known as PARP inhibitors (poly [adenosine diphosphate (ADP)-ribose] polymerase inhibitors). PARP is a protein inside cells that helps repair damage to DNA, which is the genetic material that carries the instructions for the body’s growth and development, and allows cells to continue on living. Cancer can result when there are changes in a person’s genetic material (sometimes called DNA mutations) that can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing.


The goal of this study is to evaluate the efficacy (how well the study drug works) and safety of rucaparib (the study drug) to determine whether rucaparib is a potential treatment option in people with urothelial carcinoma. The study will also evaluate the pharmacokinetics (also called PK) of the study drug. Pharmacokinetics is the way the body absorbs, distributes, and gets rid of a drug and provides information on the amount of study drug in the blood.

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 urothelial carcinoma.


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
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03397394 STU00207365
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1-888-NU-STUDY
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(xIRB) NCI CIRB: SWOG 1612: A RANDOMIZED PHASE II/III TRIAL OF “NOVEL THERAPEUTICS” VERSUS AZACITIDINE IN NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) OR HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS), AGE 60 OR OLDER (LEAP: LESS-INTENSE AML PLATFORM TRIAL)
This study includes a screening…
This study includes a screening step and a treatment step. The purpose of the screening step is to allow researchers to learn if a certain blood and bone marrow test (called a biomarker) can help predict how a person’s AML/MDS will respond to study drugs. The purpose of the treatment step of this study is to compare any good and bad effects of using different new treatment options to one of the current standard treatment options. The investigators will keep testing new treatments to see if they have any different effects on patients and their cancer when compared to the standard.
You may be able to take part in this study if you have acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and you and/or your doctor did not think you should get intensive chemotherapy.
Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207638
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Study Coordinator 312 695 1102
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An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffman-La Roche LTD-Sponsored Atezolizumab Study.

The purpose of this study is to find out what effects, good or bad, atezolizumab alone or atezolizumab combined with o…

The purpose of this study is to find out what effects, good or bad, atezolizumab alone or atezolizumab combined with other agent(s) have on you and your cancer and to provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients who were previously enrolled and treated in a parent study.

For patients who continue treatment in the extension study:

-Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study

or

- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study

- First dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study

For patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab outside the extension study and continue safety and survival follow-up only

- Discontinuation of atezolizumab-based therapy in parent study and in survival follow-up at the time of parent study closure

or

- Eligible for continuing or crossing over to atezolizumab-based therapy as per the parent protocol and have access to commercially available atezolizumab outside this extension study at the time of the parent-study closure.

Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207655
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Study Coordinator 312 695 1102
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(xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
The first purpose of this study is to te…
The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
Dinner, ShiraDinner, Shira
  • Map it 201 E. Huron St.
    Chicago, IL
STU00208162
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Study Coordinator 312 695 1102
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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects with Metastatic Castrate-Resistant Prostate Cancer (CRPC) and Relapsed/Refractory Acute Myeloid Leukemia (AML)

The purpose of this study is to see if ABBV-744 is safe, to determine a safe dose of ABBV-744, to see ho…

The purpose of this study is to see if ABBV-744 is safe, to determine a safe dose of ABBV-744, to see how much ABBV-744 is in your blood at various times (these tests are called “pharmacokinetics” or “PK”), and to determine if treatment with ABBV-744 leads to tumor shrinkage. This study is for patients with relapsed (cancer has returned) or refractory (cancer is not responding to treatment) acute myeloid leukemia.

- Must have AML diagnosis (other than promyelocytic leukemia [APL]) by morphology/flow cytometry

- Patients receiving a stem cell transplant (SCT) must have recovered from any SCT-related toxicities and have at least 6 months recovery after allogeneic SCT or 3 months after autologous SCT

- Must have relapsed or refractory AML


Frankfurt, OlgaFrankfurt, Olga
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03360006 STU00207615
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Study Coordinator 312 695 1102
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Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)

The purpose of this study is to:

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

The purpose of this study is to:

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

- Test the safety of the study drug

- See how your body handles the study drug.

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

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

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

Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
STU00208266
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Study Coordinator 312 695 1102
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