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

Clinical Trials

We're committed to providing the most advanced treatments available for patients with brain and spine tumors, and to developing clinical research that will lead to tomorrow’s standard of care.

For best results, use specific search terms (e.g., "glioblastoma" instead of "brain tumor"). We do our best to keep these listings up-to-date, but we may sometimes have trials available that are not yet listed. To inquire about other clinical trials or to learn more about the clinical trials listed here, please contact cancertrials@northwestern.edu or call 312-695-1102. You can also view a list of open Lurie Cancer Center clinical trials for all types of cancer.

Trials
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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For more information on this study please contact us:

Amidei, Christina 312 695 9124
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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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For more information on this study please contact us:

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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For more information on this study please contact us:

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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For more information on this study please contact us:

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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For more information on this study please contact us:

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

Exclusion Criteria:
•Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection.
•Immunosuppressive drugs (with exception of corticosteroid).
•Known HIV+ patients.
•Acute infections (viral, bacterial or fungal infections requiring therapy).
•Pregnant or breast-feeding patients.
•Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
•Prior radiation therapy to the brain or prior treatment for brain tumor Other serious co-morbid illness or compromised organ function
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03072134 STU00203933
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For more information on this study please contact us:

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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For more information on this study please contact us:

1-888-NU-STUDY
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