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Clinical Trials

The Northwestern Medicine Lou and Jean Malnati Brain Tumor Institute of the Lurie Cancer Center is 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 care.

For best results, use specific search terms (e.g., "glioblastoma" instead of "brain tumor") below. 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.

Watch: What is a clinical trial? A Northwestern physician explains.
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 additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it …

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
  • Map it 201 E. Huron St.
    Chicago, IL
STU00087359
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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 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 …
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, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02847559 STU00203030
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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 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 201 E. Huron St.
    Chicago, IL
NCT03994796 STU00211229
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Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be …

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

Inclusion Criteria:

  • Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4
  • Ability to undergo contrast-enhanced MRI
  • Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy
  • Measurable or evaluable disease

  • Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI
  • Non-measurable/evaluable: contrast-enhancement diameters < 1 cm
  • Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI
  • Candidate for at least partial surgical resection
  • Greater 12 weeks from completion of radiation therapy
  • Age ≥ 18 years
  • If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at < 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of < 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  • WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
  • Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration
  • For patients with a childbearing potential

  • Negative pregnancy test within 14 days prior to registration
  • Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively.
  • Have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • Be willing and able to comply with the protocol for the duration of the study
  • Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained
  • Exclusion Criteria:

  • Have multifocal disease that cannot be encompassed in the ultrasound fields:

  • e.g. > 70-mm apart
  • tumor located in the posterior fossa
  • Patients at risk of cranial wound dehiscence
  • Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
  • Have clinical evidence of peripheral neuropathy on examination
  • Have received any other investigational agents within 4 weeks of registration
  • Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
  • Medical contraindications to Abraxane® or carboplatin
  • Have an uncontrolled intercurrent illness
  • Are pregnant or nursing
  • Have a history of active malignancy within 3 years prior to registration.
  • Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study)
  • Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs.
  • Patients with medical need to continue antiplatelet therapy.
  • Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction).
  • Patients with impaired thermo-regulation or temperature sensation (due to device)
  • Sonabend Worthalter, Adam MendelSonabend Worthalter, Adam Mendel
    • Map it 675 N. Saint Clair St. Twentieth Floor
      Chicago, IL
    NCT04528680 STU00212298
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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 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 …

    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 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 …

    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
    NCT04469075 STU00213944
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