Brain tumor clinical trials open around the country all the time, and it can be hard for patients and care partners to keep track of new opportunities to consider participation in leading-edge clinical research. This report, generated by the National Brain Tumor Society, provides a summary of clinical trials that have started or begun recruitment for patients in the U.S. with primary brain tumors since our last quarterly report. To learn more about each trial, and contact the party responsible for enrolling patients, just follow the hyperlink by clicking on the title of each trial listing.
- A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE)
- Brief Description: Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed and recurrent GBM. NBTS has invested in and supported this trial. Read more here and here.
- Evaluation of LY2606368 Therapy in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors
- Brief Description: SJELIOT is a phase 1 trial that aims to explore the combination of the drug LY2606368 with the drugs gemcitabine or cyclophosphamide to evaluate the safety and activity of this treatment approach in medulloblastoma patients.
- Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitor BMS-986158 in Pediatric Cancer
- Brief Description: This phase 1 study is evaluating an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors, including brain tumors.
- 18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis
- Brief Description: The purpose of this phase 1 study is to evaluate whether 18F-fluciclovine PET/CT of the brain is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive. 18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.
- A Study of BXQ-350 in Children and Young Adults With Relapsed Solid Tumors
- Brief Description: This phase 1 study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors. All patients will receive BXQ-350 by intravenous (IV) infusion. The study is divided into two parts: Part 1 will enroll patients at increasing dose levels of BXQ-350 in order to determine the MTD. Part 2 will use the MTD to further assess the safety of BXQ-350 as well as preliminary anti-tumor activity.
- Testing the Safety and Tolerability of CX-4945 in Patients With Recurrent Medulloblastoma Who May or May Not Have Surgery
- Brief Description: This is a multicenter, Phase I/Phase II and surgical study of the CX-4945 drug (silmitasertib sodium) for patients with recurrent SHH (Sonic Hedgehog) medulloblastoma.
- Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
- Brief Description: The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well-tolerated.
- Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas (TMZ-Cap)
- Brief Description: This is a phase 2 study to assess the efficacy of capecitabine (CAP) and temozolomide (TMZ) in recurrent pituitary adenomas.
- Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis
- Brief Description: Phase 1 The investigators will develop the concept of a sex-specific therapeutic intervention for gliomas that is based upon dietary carbohydrate restriction. The investigators will integrate metabolomics tools and FDG-PET imaging to validate the ketogenic diet on a sex-specific basis.
- Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
- Brief Description: This phase 1 study will evaluate palbociclib in combination with chemotherapy (temozolomide and irinotecan) in children, adolescents and young adults with recurrent or refractory solid tumors, including malignant brain tumors.
- LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
- Brief Description: This phase 1 trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.
- Vaccine Therapy in Treating Patients With Recurrent Glioblastoma
- Brief Description: This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person’s white blood cells mixed with tumor proteins from another person’s glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.
- Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma
- Brief Description: This phase 2 clinical trial increases radiation to areas of the brain considered to be at risk for cancer. The at-risk areas are identified by a biological MRI scan. The study will look at the side effects of the radiation and overall survival.
- DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab (DERIVe)
- Brief Description: In this phase 2 trial, patients with newly diagnosed glioblastoma, following surgery, will receive an immunotherapy vaccine with dendritic cells.
- Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma
- Brief Description: In this phase 2 trial, researchers will evaluate the new drug LB100 to patients before brain tumor surgery. They will measure how much LB100 is in the blood and how much gets into the brain. This may help with the use of LB100 to treat brain tumors in the future.
- Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells
- Brief Description: In this phase 1 trial, patients will receive standard chemotherapy and Tumor Treated Fields (TTFields) and will also receive Carvedilol for 4 cycles of treatment. Peripheral glioma circulating tumor cells (CTC) and brain MRI with and without contrast will be obtained at baseline, 2 cycles, and 4 cycles to determine the efficacy and direction of change of the CTC using a new testing tool. Preliminary assessment of the tolerability of Carvedilol with standard chemotherapy will also be evaluated.
- Developing Fast Pediatric Imaging
- Brief Description: This research study is evaluating an investigational software for magnetic resonance imaging (MRI) systems, as well as techniques to process magnetic resonance (MR) images in PLGG, to see if the process can be accelerated.
- Fimepinostat in Treating Brain Tumors in Children and Young Adults (PNOC016)
- Brief Description: This phase 1 trial studies how well fimepinostat works in treating patients with newly diagnosed diffuse intrinsic pontine glioma, or medulloblastoma, or high-grade glioma that have come back. Fimepinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Feasibility of the LUM Imaging System for Detection of Cancer in the Brain
- Brief Description: The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.
- A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas
- Brief Description: This phase 2 trial will evaluate the activity of Panobinostat in combination with Everolimus for children with gliomas harboring a H3.1 or H3.3K27M mutation, including newly diagnosed high-grade glioma or DIPG (diffuse intrinsic pontine glioma) after radiation (stratum A) and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).
- Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
- Brief Description: This phase I trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in predicting tumor growth in patients with meningiomas. Giving Gallium Ga 68-DOTATATE before PET/CT scan may work better in predicting tumor growth in patients with meningiomas.
- Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
- Brief Description: This single-arm, open-label phase 2 study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma.
- Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Glioblastoma
- Brief Description: This advanced imaging approach will be evaluated to determine if it is able to more accurately and more quickly determine if a tumor is responding to a treatment or not.
- Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma
- Brief Description: This phase 2 research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can 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.
- F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
- Brief Description: This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.
- FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma (FORWARD)
- Brief Description: This is a phase 2, multi-institutional, historically-controlled, study of 100 patients with newly diagnosed Grade II and III astrocytoma comparing the combination of TTFields with adjuvant temozolomide versus temozolomide alone in historical controls after the completion of definitive chemoradiotherapy. Study treatment may continue past first tumor recurrence. The primary endpoint will be overall survival.
- Abemaciclib in Patients With Oligodendroglioma
- Brief Description: This is a phase II, single-arm, open-label study evaluating how well a drug called abemaciclib works in patients with recurrent oligodendroglioma
- Oncolytic Adenovirus DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
- Brief Description: This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.
- Study of Stereotactic Radiosurgery to the Subventricular Zone in Malignant Gliomas
- Brief Description: During participation in this phase 1 clinical trial, targeted radiation to the subventricular zone of the brain is given in addition to standard of care radiation and chemotherapy in patients with malignant gliomas.
- Resting-State Functional MRI in Glioma Patients Before and After Surgery
- Brief Description: This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.
- Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
- Brief Description: The purpose of the phase 1 study is to estimate the ability of mirtazapine to reduce depression, nausea, and vomiting, and maintain weight in depressed glioma patients undergoing Temozolomide (TMZ) therapy. Of equal importance, the investigators will monitor the tolerability of Mirtazapine in these patients over the course of the study.
For a more comprehensive list of ALL open brain tumor clinical trials, please visit the NBTS Clinical Trial Finder at trials.braintumor.org, where you can search potential opportunities for enrollment based on criteria important and specific to you.