New Brain Tumor Clinical Trials: July- December 2022

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, and this report provides a summary of the studies that have recently opened or started for patients with a primary brain tumor*. Follow the hyperlink above to learn more about each trial and to contact the party responsible for enrolling patients.** 

• Surgical Pembro +/- Olaparib w TMZ for rGBM
  • A phase II study to evaluate combinations of an immunotherapy and DNA Damage Response Inhibitor drug as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. (Note: NBTS has provided funding for this trial in association with our DNA Damage Response Consortium).
• Trial of Dichloroacetate (DCA) in Glioblastoma (GBM)
  • A phase II study to evaluate the effects of the drug dichloroacetate (DCA) for recurrent glioblastoma patients planning to undergo surgery.
• Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
  • An early phase I study to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult patients with glioblastoma after carmustine wafer placement.
• Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma (PRIDE)
  • A phase I/II trial to evaluate the use of the drug daratumumab in combination with temozolomide and radiation in newly diagnosed GBM patients.
• A Drug-drug Interaction Study of Avapritinib and Midazolam
  • A phase I trial to investigate the effect of multiple dosing levels of avapritinib on the pharmacokinetics (PK) of midazolam in adult patients with metastatic or unresectable gastrointestinal stromal tumors (GIST), recurrent gliomas, or other KIT mutant tumors.
• Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
  • This phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). 
• A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma (MAGIC-G1)
  • A phase I study to assess the safety of MTX-110 alone and in combination with lomustine for patients with recurrent glioblastoma.
• A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors, Including Glioblastoma
  • A phase I study to investigate the safety, tolerability, and dose-limiting toxicity, as well as to determine maximally tolerated dose and recommended phase II dose to be used in subsequent development of the drug PRT3645.
• A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM (FRONTIER)
  • An early phase I trial evaluating the safety and technical feasibility of TheraSphere GBM device (a type of radiation-delivering treatment) in patients with recurrent GBM.
• Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive Enhancing IDH-1 Mutant Astrocytomas
  • A phase I trial evaluating the combination of the drugs vorasidenib and pembrolizumab in participants with recurrent or progressive enhancing isocitrate dehydrogenase-1 (IDH-1) mutant astrocytoma.
• Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients
  • A phase I/II trial to evaluate the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and the potential efficacy of the drug SKL27969 in patients with advanced solid tumors, including those with recurrent high-grade gliomas.
• NEO100 and High-Grade Meningioma
  • A phase II trial to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma, or recurrent high-grade meningioma.
• Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma
  • A phase II trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children under the age of five with newly diagnosed medulloblastoma.
• 18F-Fluciclovine PET-MRI in High-grade Glioma
  • An early phase I trial to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with high-grade gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.
  • Similar study happening as a phase III trial
• Blood-Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
  • A phase I/II study is to evaluate the safety and efficacy of targeted blood-brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with doxorubicin therapy for the treatment of DIPG in pediatric patients.
• FearLess in Cognitively Intact Patients With Glioma (FearLess)
  • This study will assess the preliminary feasibility and acceptability of FearLess, a newly developed psychological intervention for fear of cancer recurrence (FCR) among cognitively-intact patients with glioma.
• ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (ACTION)
  • This phase III in patients with newly diagnosed H3 K27M-mutant diffuse glioma will assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
• Registering Genomics and Imaging of Tumors (ReGIT)
  • An early phase I study investigating how glioma brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.
• Niraparib In Recurrent IDH 1/2 Gliomas
  • A phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant, non-enhancing glioma. This research study involves an experimental treatment called Niraparib.
• All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
  • A phase II study of the combination of All-Trans Retinnoic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patients with recurrent IDH-mutant glioma. 
• Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma
  • An early phase I study for newly diagnosed glioblastoma patients evaluating treatment with fractionated stereotactic radiotherapy (FSRT) for two weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug.
• GammaTile and Stupp in Newly Diagnosed GBM (GESTALT)
  • A phase IV study to assess the feasibility and tolerability of adding GT radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach for patients with newly diagnosed GBM. 
• Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma
  • This phase I/Ib trial tests the safety, side effects, and best dose of mycophenolate mofetil in combination with temozolomide and/or radiation therapy (standard of care) in treating patients with glioblastoma. 
• B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma 
  • This is a phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3 CAR-T into the central nervous system of adult subjects with recurrent IDH-wildtype GBM.
• Tofacitinib in Recurrent GBM Patients
  • A phase III trial to examine the effects of the drug tofacitinib in patients with recurrent glioblastoma
• Simulation-Based Caregiving Skills Training for Family Members of High-Grade Glioma Patients
  • This study will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve glioma caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.
• Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
  • A study to adapt the CALM intervention to the specific needs of caregivers in neuro-oncology.
• Quantitative Assessment of Radiation-induced Neuroinflammation – A Proof of Principle Study (QARIN 1)
  • A phase II study of [18F]DPA-714 Translocation Protein (TSPO) Positron Emission Tomography (PET) for longitudinal, quantitative assessment of brain neuroinflammation following whole brain radiation therapy in medulloblastoma patients.
• RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors (PIRATE)
  • The phase I PIRATE study tests the experimental drug RRx-001 in combination with two chemotherapy drugs that are commonly used in patients with cancer. RRx-001 has been used alone and with other anti-cancer medicines in adults. However, the investigators do not know what effects it will have in children and young adults.
• Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With Glioblastoma 
  • The purpose of this study is to evaluate the safety and efficacy of targeted blood-brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in patients with glioblastoma.
• F-Tryptophan PET/CT in Human Cancers
  • In this phase I study, researchers will compare the uptake of the tracer on F-Tryp PET/CT in patients with cancers, including certain malignant brain tumors, specifically, to evaluate whether the tumors show increased tracer uptake as compared to non-tumor tissues, using F-Tryp PET/CT.
• Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
  • This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy vs. the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent).
• A Study to Determine How BI 907828 is Taken up in the Tumor and to Determine the Highest Dose of BI 907828 That Could be Tolerated in Combination With Radiation Therapy in People With Glioblastoma
  • This phase I study is open to adults with newly diagnosed glioblastoma. The study has two parts: Part 1 is open to people who can get their brain tumor removed by surgery, and Part 2 is open to people who already had such a brain surgery. The trial will evaluate a medicine called BI 907828. 
• A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors
  • A phase I clinical trial to learn the safety and effects of the study medicine (PF-07799544) administered alone and in combination with other study medications in people with advanced solid tumors, including certain malignant brain tumors. 
• Oral AMXT 1501 Dicaprate in Combination With IV DFMO
  • A phase Ib/IIa study to establish safety and dose level of the drug AMXT 1501 dicaprate in combination with intravenous (IV) delivery of the drug DFMO, in cancer patients, including certain adult and pediatric glioma patients.
• Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma
  • The purpose of this research is to find hidden cancer with an experimental magnetic resonance imaging (MRI) scan called spectroscopic magnetic resonance imaging (sMRI). That spectroscopic MRI scan will be used to increase the area of the brain receiving radiation and then the dose of radiation in an attempt to kill more of the cancer. Proton radiotherapy and bevacizumab (Avastin) are used to minimize the possible side effects of this approach.
• Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
  • A phase I study to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma.
• A Phase I/II Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2 in Patients With DIPG
  • A phase I/II trial to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type-2 device and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in patients with diffuse intrinsic pontine glioma (DIPG).

TAGGED WITH: low-grade glioma, ATRT, Clinical trials, glioma, DIPG, meningioma, astrocytoma, Medulloblastoma, high-grade glioma, glioblastoma, Oligodendroglioma, brain tumor, brain cancer