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Behavioral Neurology Trials

As part of an academic medical center, the Division of Behavioral Neurology at Northwestern University Feinberg School of Medicine aims to improve human health through scientific research. Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

The following searchable list includes all the behavioral neurology clinical trials currently looking for participants.

Trials
NUDB 13C03: Northwestern Brain Tumor Institute Research Database

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

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

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

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

Kumthekar, Priya UKumthekar, Priya U
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    Chicago, IL
STU00087359
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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

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

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

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

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

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

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02523014 STU00202953
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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, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02796261 STU00203957
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(xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

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

therapy. Photon…

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

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

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

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

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

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

-Participants must be 18 years of age or older

-Participants must be diagnosed with a brain tumor

Stupp, RogerStupp, Roger
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03180502 STU00209631
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(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

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

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

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

  • Participantsmust be 18 years or older

  • Participants must have a confirmed diagnosis of cancermetastasized to the brain
Kumthekar, Priya UKumthekar, Priya U
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03994796 STU00211229
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(xIRB) NCI CIRB Alliance A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

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

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

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

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

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

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

Participants 18 years or older who have resected metastatic brain disease. 
Sachdev, SeanSachdev, Sean
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04114981 STU00211282
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(xIRB) DRUG AG881-C-004: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of AG-881 in Subjects with Residual or Recurrent Grade 2 Glioma with an IDH1 or IDH2 Mutation
The main purpose of this research study is to investigate the safety and efficacy (usefulness) of AG-881 as…
The main purpose of this research study is to investigate the safety and efficacy (usefulness) of AG-881 as compared to placebo (a medically inactive substance) in subjects with residual or recurrent Grade 2 glioma that have an IDH1 or IDH2 mutation.

Some of the eligibility criteria include:

  • Participants must be 18 or older.
  • Be able to understand and willing to sign informed consent and willing to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including serial peripheral blood sampling and urine sampling, during the study.
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, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04164901 STU00211620
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(xIRB) DRUG XPORT-GBM-029: A Phase 1/2 Study of Selinexor in Combination with Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma
The purpose of this research study is to see if the combination of approved Glioblastoma (GBM) medications, together with the study drug, selinexo…
The purpose of this research study is to see if the combination of approved Glioblastoma (GBM) medications, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor is approved by the U.S. Food and Drug Administration (FDA) for the use in certain patients with multiple myeloma but is considered to be investigational for the use in GBM. Investigational means that it has not been approved by the FDA, Health Canada, or any other regulatory agencies for the treatment of GBM.

This is an open-label study, which means that both you and your study doctor will know how much selinexor and the names of the other medications you are taking. This study includes the following different treatment combination arms:

•Arm A – Selinexor plus radiation treatment in patients with newly diagnosed, unmethylated GBM

•Arm B – Selinexor plus temozolomide (TMZ) and radiation treatment in patients with newly diagnosed, methylated GBM

•Arm C – Selinexor plus lomustine in patients with recurrent GBM

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Your study doctor will decide which combination is right for you, based on what therapies are available in your location and based on your diagnosis and treatments you have had in the past.

There are two parts of this study. The first part is a “dose-escalation phase,” where the purpose is to find the best dose and the best treatment schedule of the above combinations, based on how well the medications work together and how safe they are when they are given together. The second part, the “dose-expansion phase,” will be used to see how well the best dose and treatment schedule from part 1 works when given to a larger group of patients.

If you are assigned to Arm A or B for the dose-expansion phase and are assigned to the control treatment, you will receive a maximum of 7 cycles of treatment which is consistent with what the FDA or other regulatory agency has approved. If you are a part of the dose-escalation phase of Arm A or B, the dose-expansion phase for Arm A or B and are assigned to the treatment arm, or if you are assigned to Arm C, you can continue to receive study treatment as long as your doctor thinks you are benefitting from therapy, until the study ends, your disease progresses, you have side effects that makes you want to not continue, you decide to withdraw from the study, your study doctor decides you should not continue, or you become pregnant (if applicable).

For each visit, your study doctor will review your data and perform some tests to see if it is appropriate for you to continue in this study. Selinexor, the study drug, comes in tablet form and should be swallowed whole with about one-half of a cup of water. Selinexor can be taken with or without food.

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

Some of the eligibility criteria include:

•Age of at least 18 years

•Newly Diagnosed or Recurrent Glioblastoma

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, Priya UKumthekar, Priya U
  • Map it 251 E. Huron St.
    Chicago, IL
NCT04421378 STU00213433
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NRG BN007: A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients with Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma
This study is being done to answer the following question: Can we lengthen time without…
This study is being done to answer the following question: Can we lengthen time without your brain tumor returning or growing and can we extend your life by replacing the usual chemotherapy with immune therapy? We are doing this study because we want to find out if this approach is better, the same, or worse than the usual approach for your brain tumor. The usual approach is defined as care most people get for glioblastoma brain tumors.
  • Participants must be 18 years or older
  • Participants must have a confirmed diagnosis of newly diagnosed Glioblastoma with a specific biomarker known as unmethylated MGMT.
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.
Dixit, Karan SinghDixit, Karan Singh
  • Map it 251 E. Huron St.
    Chicago, IL
NCT04396860 STU00213865
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(xIRB) NCI CIRB Alliance A071702: A Phase II Study of Checkpoint Blockade Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma

The purpose of this study is to test the good and bad effects of the combination of immunotherapy drugs

called nivolumab and ipilimumab. T…

The purpose of this study is to test the good and bad effects of the combination of immunotherapy drugs

called nivolumab and ipilimumab. The study doctors hope to learn if the study drugs will lead to a

stability or reduction in the size of your tumor.

Nivolumab and Ipilimumab have already been approved by the FDA to treat other cancers.

In this study, if your tumor has a higher number of mutations, you will receive a combination of

nivolumab and ipilimumab every three weeks for four cycles and then you will receive nivolumab alone

every four weeks as long as you keep responding to it and do not experience any serious side effects.

If your tumor starts to grow while receiving the medication, we will stop treating you with it.

After you finish your study treatment, your doctor will continue to follow your condition every 3

months for 3 years and watch you for side effects.

Participants age 18 years or older who have a glioblastomawhich has recurred (come back) or gotten bigger after initial treatment will beenrolled into this study.

Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04145115 STU00214358
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(xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

The purpose of this study is…

The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

(whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

This study will help the study doctors find out if this different approach is better, the same,

or worse than the usual approach.

Memantine is FDA approved for treating dementia and is commonly used off-label

(that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

radiation therapy for cancer that has spread to the brain.

This study has 2 study groups. You will be told which group you are in.

Group 1

If you are in this group, you will get the usual treatment, SRS. In addition to the usual

SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

Group 2

If you are in this group, you will get the usual treatment of SRS.

After you finish your treatment, your doctor and study team will watch you for side effects and

follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

Lukas, Rimas VincasLukas, Rimas Vincas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04588246 STU00214371
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NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields …

Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

Key eligibility criteria include:

  • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
  • Able to self-administer topical interventions or has available another person who can apply the topical agents
  • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
  • Age of at least 18 years old

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

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, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
STU00213944
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