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

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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(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 photontherapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam ofproton particles to send radiation inside the body to the tumor. This study will allow …
The purpose of this study is to compare any good and bad effects of using proton therapy to using photontherapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam ofproton particles to send radiation inside the body to the tumor. This study will allow the researchers to knowwhether proton therapy is better, the same, or worse than the usual approach. Proton therapy may have lessnegative effects on brain function than photons because less brain is exposed to radiation when proton therapyis 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 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 olderParticipants 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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(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 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 …
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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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 4Ability to undergo contrast-enhanced MRIRadiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapyMeasurable or evaluable diseaseMeasurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRINon-measurable/evaluable: contrast-enhancement diameters < 1 cmMaximal tumor diameter pre-surgery ≤ 70 mm on T1wMRICandidate for at least partial surgical resectionGreater 12 weeks from completion of radiation therapyAge ≥ 18 yearsIf 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 registrationFor patients with a childbearing potentialNegative pregnancy test within 14 days prior to registrationAgreement 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 studyBe willing and able to comply with the protocol for the duration of the studyProvide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtainedExclusion Criteria:Have multifocal disease that cannot be encompassed in the ultrasound fields:e.g. > 70-mm aparttumor located in the posterior fossaPatients at risk of cranial wound dehiscenceHave uncontrolled epilepsy or require treatment with enzyme-inducing antiepilepticsHave clinical evidence of peripheral neuropathy on examinationHave received any other investigational agents within 4 weeks of registrationHave received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatinMedical contraindications to Abraxane® or carboplatinHave an uncontrolled intercurrent illnessAre pregnant or nursingHave 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 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. 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 …
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 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 institutionAble to self-administer topical interventions or has available another person who can apply the topical agentsTreatment with TTF should be initiated within 7 days of planned initiation in this trialAge of at least 18 years oldAll 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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