Northwestern University Feinberg School of Medicine
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Lou and Jean Malnati Brain Tumor Institute

Clinical Trials

The Northwestern Medicine Lou and Jean Malnati Brain Tumor Institute of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University at Northwestern Memorial Hospital is committed to providing the most advanced treatments available for our patients with brain tumors, and to developing clinical research that will lead to tomorrow’s standard of care.

For best results, use specific search terms. For example, instead of "brain tumor," try "glioblastoma." For assistance, or additional information about the clinical trials listed here. please contact cancertrials@northwestern.edu or call 312-695-1102. View a list of all open Lurie Cancer Center clinical trials.

Trials
A071102: A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temo…
This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
Participants must be 18 years of age or older. Participants must have a type of brain tumor called a glioblastoma multiforme (GBM) and have completed the first part of treatment with radiation combined with the chemotherapy drug temozolomide (TMZ).
Kumthekar, PriyaKumthekar, Priya
NCT02152982 STU00200312
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Study Coordinator 1-888-NU-STUDY
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A Phase II, Open Label, Clinical Trial Of Pre-Surgical and Adjuvant Treatment of Recurrent Glioblastoma with Tremelimumab and Durvalumab (MEDI4736) Alone and in Combination To Determine Immunologic Changes From Treatment
The main purpose of this trial is to investigate the effects of a …
The main purpose of this trial is to investigate the effects of a new class of drugs that help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These drugs have already shown benefit in some other cancer types and are now being explored in GBM. Both tremelimumab and durvalumab (MEDI4736) are "investigational" drugs, which means that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by 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 glioblastoma.
Some of the eligibility criteria include:

- Patients must be age = 18 years. Both male and female are eligible.
- Patients must have a grade III or IV glioma that has failed standard RT and TMZ.
- Patients must have had radiographic evidence of tumor progression by brain MRI or CT scan.
- Patients must be surgical candidates.

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.
Bloch, OrinBloch, Orin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02794883 STU00202283
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Study Coordinator 312 695 1102
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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations
This phase II trial studies how well 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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Study Coordinator 1-888-NU-STUDY
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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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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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Prospective Phase II Study of Cytochrome C Oxidase Activity as a Novel Biomarker In Subjects With Newly Diagnosed Primary Glioblastoma Multiforme
This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (time intervals from dates of diagnosis to death from a…
This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (time intervals from dates of diagnosis to death from any cause) of a subject with newly diagnosed primary GBM tumors, treated by standard of care (SOC), is a function of the CcO enzymatic activity in the tumor.
Patients older than 21 years of age with an MRI that is consistent with primary GBM may be eligible for this clinical trial. This biomarker study will require patients to consent (pre-resection) for their tumor tissue to be collected and analyzed for enzymatic activity.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203783
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Coffey, Taylor 312 503 1819
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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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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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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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DRUG MRZ-112: Phase 1B, Multicenter, Open-Label Study of Marizomib Combined with Temozolomide and Radiotherapy in Patients with Newly Diagnosed WHO Grade IV Malignant Glioma
The specific purposes of this study are to: - Determine the best dose of MRZ to be given in combination with the standard trea…
The specific purposes of this study are to: - Determine the best dose of MRZ to be given in combination with the standard treatment, TMZ and RT and Optune. - Evaluate any preliminary evidence of anticancer activity of MRZ for treating malignant glioma when combined with TMZ and RT and Optune. - Find out what, if any, side effects (good and bad) MRZ has on your body. - Measure the amount of MRZ and TMZ in a participant depending on which treatment group they are enrolled.
Participants must be 18 years of age or older and have been diagnosed with a malignant (cancerous) brain tumor, which is also known as a ‘glioma,’ or a ‘glioblastoma’.
Stupp, RogerStupp, Roger
NCT02903069 STU00205711
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Study Coordinator 1-888-NU-STUDY
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