New Brain Tumor Clinical Trials: April – October 2024

It can be hard to keep track of new clinical trial opportunities opening across the United States. There are many clinical trials actively enrolling patients. This report provides a summary of the studies that have recently opened or started recruiting since our last report for patients with a primary brain tumor. Follow the hyperlink for each study to learn more and to contact the party responsible for enrolling patients.** 

For a comprehensive list of ALL open brain tumor clinical trials, visit the NBTS Clinical Trial Finder, where you can search for potential opportunities for enrollment based on criteria specific to you.

• Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)
  • A phase I trial in patients undergoing a clinically-indicated craniotomy for resection of recurrent tumors to investigate the ability of the drug, xevinapant, to cross the blood-brain barrier and exert anti-tumor effects on rHGG tumors through activation of apoptosis. 
• Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
  • The purpose of this phase I study is to find the biggest dose of CARE T cells that is safe, to see how long they last in the body, to learn what the side effects are, and to see if the CARE T cells will help people with GPC3-positive solid tumors, including certain pediatric brain tumors.
• Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT) 
  • This is a phase 1 study treating children with embryonal brain tumors after definitive resection to assess the safety and feasibility of multi-tumor antigen-specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient’s primary brain tumor tissues.
• Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma, Ependymoma, and Other CNS Malignancies
  • The goal of this phase I clinical trial is to assess the safety, toxicity, and antitumor activity of fourth ventricular infusions of nivolumab plus 5-azacytidine for recurrent ependymoma and nivolumab plus methotrexate for recurrent medulloblastoma and other CNS malignancies. Additionally, the study will explore immunologic responses to nivolumab.
• Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/​2/​3 or ROS1-FUSED CNS Tumors
  • This phase II clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high-grade glioma, or other central nervous system (CNS) tumors.
• Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Oncolytic HSV1 MVR-C5252 (PuMP)
  • This is a phase I trial to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate the preliminary efficacy of the study drug.
• An Investigational Scan (Ga-68 PSMA-11 PET/​CT) for Detection of Disease Recurrence or Progression in Patients with Glioma
  • This phase II trial evaluates whether gallium-68 (Ga-68) prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma.
• DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
  • A phase II study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable, or unresectable disease and increase the time that disease is controlled.
• Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
  • A phase I trial to find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.
• Glioblastoma Remote Monitoring and Care
  • The purpose of this research is to learn more about how participants feel relates to what the Apple watch measures — walking data, heart rate, breathing rate, and sleep habits. Ultimately, this knowledge is being used to design proactive tools and signatures that can predict complications or symptom changes before they happen.
• Lerapolturev (PVSRIPO) in GBM
  • A phase II research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma.
• Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma
  • A phase I study of combination drug therapy based on personalized cancer stem cell (CSC) high-throughput drug screening (HTS) with standard of care for newly diagnosed glioblastoma.
• Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
  • A randomized phase II study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.
• WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
  • This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma.
• Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/​IL-13Ralpha2 CAR (E-SYNC) T Cells
  • This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma.
• N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
  • This is a phase II study to evaluate the safety and efficacy of N-803 and PD-L1 t-haNK when combined with bevacizumab in subjects with recurrent or progressive GBM.
• PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
  • This phase II study will assess whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).
• Study of Ribociclib and Everolimus in HGG and DIPG
  • A phase II trial to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target. The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG, including DIPG.
• ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
  • A phase I trial to evaluate the feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.
• HSV G207 with a Single Radiation Dose in Children with Recurrent High-Grade Glioma
  • A phase II clinical trial to assess the efficacy and confirm the safety of intratumoral inoculation of G207 (an experimental virus therapy) combined with a single 5 Gy dose of radiation in recurrent/progressive pediatric high-grade gliomas.
• Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
  • This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. 
• Atovaquone Combined with Radiation in Children with Malignant Brain Tumors (AflacBT2303)
  • A phase I study to evaluate the safety and tolerability of the drug atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma/diffuse midline glioma/diffuse intrinsic pontine glioma (pHGG/DMG/DIPG). The secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of RT and before progression.
• CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial (CBT-I in PBT)
  • A phase II study to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population.
• A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
  • The goal of this phase III clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma (GBM).
• Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors
  • A phase I study to learn about the safety and feasibility of giving a personalized DNA vaccine to pediatric patients with brain tumors that have returned or have been resistant to treatment.
• Intratumoral Injections of Natural Killer Cells for Recurrent Malignant Pediatric Brain Tumors (PNOC028)
  • This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive).
• Development of MRF for Characterization of Brain Tumors After Radiotherapy
  • The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 minutes for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain.
• Radiologic Pathologic Correlation of Imaging to Distinguish True Progression From Pseudoprogression in Brain Malignancies
  • A phase I trial to learn if advanced imaging methods can tell apart true progression (the disease has actually gotten worse) from pseudoprogression (the disease appears to have gotten worse, but it actually has not).
• Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients with History of Cranial Radiation Therapy
  • This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not.
• RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma 
  • This is a Phase I study to demonstrate the manufacturing feasibility, safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma.
• Fitness and Nutrition in Glioma
  • This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.
• Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults
  • An early phase I trial to learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors.
• Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
  • This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA, including certain brain and spinal tumors.
• Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma
  • This phase I trial investigates the side effects and best dose of Peposertib, and to see how well it works in combination with radiation therapy in treating patients with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma.

TAGGED WITH: Oligodendroglioma, glioblastoma, Medulloblastoma, astrocytoma, meningioma, DIPG, gliomas, glioma, Clinical trials, Ependymoma, DMG