It can be hard to keep track of new clinical trial opportunities opening across the United States, especially during the current public health crisis created by the coronavirus (COVID-19). However, there are many clinical trials still actively enrolling patients, and this report provides a summary of the studies that have recently opened or started for primary brain tumor patients*. To learn more about each trial, and contact the party responsible for enrolling patients, just follow the hyperlink.**
- Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
- Brief Description: The primary objective of this phase I trial is to determine the maximum tolerated dose (MTD), food effect, safety, and tolerability of oral ONC206 in patients with recurrent, primary brain and CNS tumors.
- Brief Description: The primary objective of this phase I trial is to determine the maximum tolerated dose (MTD), food effect, safety, and tolerability of oral ONC206 in patients with recurrent, primary brain and CNS tumors.
- A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors
- Brief Description: This phase I trial’s purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors, including certain brain tumors.
- A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging
- Brief Description: The purpose of this phase II trial is to evaluate the tolerability of a ketogenic diet in conjunction with metformin, and whether maintaining and the diet with metformin will have any effect on adult high-grade patients. Participants will prepare their own meals with the help of a nutritionist.
- Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
- Brief Description: This is a single-arm trial to examine the feasibility of a mobile health application, Elly, to reduce levels of anxiety, stress, loneliness, and social isolation in cancer patients and survivors (including brain cancer patients). Participants will be given access to the Elly phone application and will be asked to complete questionnaires measuring quality of life at multiple timepoints during the study.
- Brief Description: This is a single-arm trial to examine the feasibility of a mobile health application, Elly, to reduce levels of anxiety, stress, loneliness, and social isolation in cancer patients and survivors (including brain cancer patients). Participants will be given access to the Elly phone application and will be asked to complete questionnaires measuring quality of life at multiple timepoints during the study.
- Study of Pamiparib in Newly Diagnosed and Recurrent GBM
- Brief Description: This is a phase 0/II study that will enroll up to 30 participants with newly diagnosed and recurrent glioblastoma. The trial will be composed of a phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an exploratory phase II component. Participants with tumors demonstrating a response in the phase 0 component of the study will graduate to an exploratory phase II trial that combines therapeutic dosing of pamiparib plus fractionated radiotherapy (for unmethylated MGMT promoter newly-diagnosed cases), pamiparib plus fractionated radiotherapy (for recurrent cases), or olaparib plus fractionated radiotherapy (recurrent cases).
- Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
- Brief Description: This is a dose-range finding phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.
- Brief Description: This is a dose-range finding phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.
- Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
- Brief Description: This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype, historically lower-grade gliomas or non-histological molecular glioblastomas. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions.
- Brief Description: This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype, historically lower-grade gliomas or non-histological molecular glioblastomas. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions.
- Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection
- Brief Description: The primary goal of this phase I study is to determine if a new investigational drug, OS2966, when delivered directly to the brain of adult participants with recurrent/progressive high-grade glioma (HGG) is safe and well-tolerated. To be eligible for this study participants must require surgical resection of their recurrent HGG.
- Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma
- Brief Description: This phase I trial investigates the side effects of brain tumor-specific immune cells (IL13Ralpha2-CAR T cells) in treating patients with leptomeningeal disease from glioblastoma, ependymoma, or medulloblastoma.
- Trametinib and Everolimus for the Treatment of Pediatric and Young Adult Patients With Recurrent Low-Grade Gliomas (PNOC021)
- Brief Description: This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with low-grade gliomas that have come back (recurrent).
- Brief Description: This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with low-grade gliomas that have come back (recurrent).
- Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas
- Brief Description: NUV-422-02 is a first-in-human, phase I/II dose escalation, and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas.
- Brief Description: NUV-422-02 is a first-in-human, phase I/II dose escalation, and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas.
- Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma
- Brief Description: A phase 0 trial of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous (IV) aminolevulinic acid HCl (ALA) to assess safety and efficacy in up to 30 participants with recurrent high-grade glioma. Eligible participants who are scheduled for resection will be administered IV ALA approximately six to seven (6-7) hours prior to receiving SDT.
- Brief Description: A phase 0 trial of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous (IV) aminolevulinic acid HCl (ALA) to assess safety and efficacy in up to 30 participants with recurrent high-grade glioma. Eligible participants who are scheduled for resection will be administered IV ALA approximately six to seven (6-7) hours prior to receiving SDT.
- A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioblastoma With Elevated Mutational Burden
- Brief Description: This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations.
- Brief Description: This phase II trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations.
- Pivotal, Randomized, Open-label Study of Optune® Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)
- Brief Description: To pivotal trial to confirm the effectiveness and safety of Optune given with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune and maintenance temozolomide are continued following radiation therapy.
- PVSRIPO and Pembrolizumab in Patients With Recurrent Glioblastoma (LUMINOS-101)
- Brief Description: This phase II trial in patients with recurrent GBM will characterize the efficacy, safety, tolerability, and initial efficacy of PVSRIPO intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every 3 weeks, thereafter.
- Brief Description: This phase II trial in patients with recurrent GBM will characterize the efficacy, safety, tolerability, and initial efficacy of PVSRIPO intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every 3 weeks, thereafter.
- Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (MEN-301)
- Brief Description: This phase III trial is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of meningiomas during tumor resection surgery.
- Brief Description: This phase III trial is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of meningiomas during tumor resection surgery.
- Exablate Blood-Brain Barrier Disruption for the Treatment of Recurrent GBM in Subjects Undergoing Carboplatin Monotherapy
- Brief Description: The purpose of this phase I/II trial is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
- Brief Description: The purpose of this phase I/II trial is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
- Ommaya Reservoir Placement for Brain Tumor Biomarker Access
- Brief Description: The purpose of this trial is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for a brain tumor. The Ommaya reservoir will facilitate longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.
- Associated study
Below is a list of phase III clinical trials that are currently enrolling patients as recorded at the close of 2020. A phase III clinical trial is traditionally the last, pivotal step in the evaluation of a potential new medicine before it is approved for use by all patients with the indicated disease.
Many of these are trials of a “novel/investigational agent” – meaning it is the first time a particular treatment is being tried for brain tumor patients. There are also a number of trials with therapies already in use for some brain tumor patients, for which researchers are evaluating these existing treatments in different combinations, different dosing regimens, and/or specific subgroups of patients.
Phase III Clinical Trials with Novel/Investigational Agents
- A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE)
- Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
- Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma
- Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (MEN-301)
- Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR STUDY)
- A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
- A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
- Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
- Pivotal, Randomized, Open-label Study of Optune® Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)
Phase III Clinical Trials with Prior/Known Agents
- A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low-Grade Glioma
- Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low-Grade Glioma
- Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma
- Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma (CSCRGBM)
- Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
*For a more comprehensive list of ALL open brain tumor clinical trials, 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.
**For additional navigation support, you can access NBTS’s Personalized Support and Navigation program by emailing patientnavigator@braintumor.org. Our Patient Navigator, Mary Lovely, PhD, RN, CNRN, has more than 30 years of experience working closely with brain tumor patients and families as a neurological nurse, clinical nurse specialist, and research nurse. To learn more visit here.