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NBTS Brain Tumor Clinical Trials Report: Q2 2020

It can be hard for patients and care partners to keep track of new clinical trial opportunities opening across the country, especially during the current public health crisis created by the coronavirus (COVID-19). However, there are many brain tumor clinical trials still actively enrolling patients, and this report provides a summary of the studies that have recently opened or started. To learn more about each trial, and contact the party responsible for enrolling patients, just follow the link provided under the brief description of each listing.


  • A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
    • Brief Description: This is a global, phase I/II, multicenter, open-label study. For phase I, the purpose of this study is to assess the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), preliminary efficacy, and safety of selinexor in combination with standard of care therapy for newly diagnosed glioblastoma multiforme (GBM) (nGBM) or recurrent GBM (rGBM). The study will independently evaluate 3 different combination regimens in 3 treatment arms in participants with nGBM O6-methylguanine-DNA-methyltransferase [MGMT] promotor unmethylated [uMGMT] disease in Arm A, MGMT methylated [mMGMT]) in Arm B, and participants with rGBM regardless of MGMT status in Arm C. The second phase of the study will compare selinexor+SoC treatments versus SoC treatment alone in the three treatment Arms.
    • LINK
  • Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
    • Brief Description: A phase I study to learn the highest dose of selinexor that people with brain cancer can tolerate when given with temozolomide and radiation therapy.
    • LINK
  • AflacST1901: Peds WP1066
    • Brief Description: In this phase I clinical study, the investigators plan to offer investigational treatment with the novel JAK2/STAT3 inhibitor WP1066 (Moleculin Biotech, Inc.) to pediatric patients with any progressive or recurrent malignant brain tumor that is refractory to standard treatment and is without known cure.
    • LINK
  • Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator
    • Brief Description: The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.
    • LINK
  • Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study (HiPPI)
    • Brief Description: This phase II trial studies how well hypofractionated proton or photon radiation therapy works in treating patients with brain tumors.
    • LINK
  • Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
    • Brief Description: This phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma (GBM) patients.
    • LINK
  • 9-ING-41 in Pediatric Patients With Refractory Malignancies
    • Brief Description: This phase I study will assess the efficacy of 9-ING-41 in pediatric patients with advanced malignancies, including pediatric brain tumors.
    • LINK
  • Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma (DRI)
    • Brief Description: This phase I study is being conducted to find out if the safety and tolerability of an experimental cell therapy is safe to administer to patients with a newly diagnosed glioblastoma multiforme (GBM) in combination with temozolomide (TMZ).
    • LINK
  • C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)
    • Brief Description: This phase I study is for patients with high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) and aims to find the largest safe dose of GD2-C7R T cells, and also to evaluate how long they can be detected in the blood and what affect they have on DIPG/HGG.
    • LINK
  • Implantable Microdevice In Primary Brain Tumors
    • Brief Description: This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.
    • LINK
  • Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
    • Brief Description: This phase I trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high-grade brain lesions. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.
    • LINK 
  • LITT Followed by Hypofractionated RT for Recurrent Gliomas (GCCC 19140)
    • Brief Description: A phase I study to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.
    • LINK
  • AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery
    • Brief Description: This phase I trial studies how well AXL inhibitor BGB324 works in treating participants with glioblastoma that has come back who are undergoing surgery.
    • LINK
  • D2C7-IT With Atezolizumab for Recurrent Gliomas
    • Brief Description: This is a phase I study of atezolizumab in combination with D2C7-IT, a dual-specific monoclonal antibody (mAB) with a high affinity for both EGFRwt- and EGFRvIII-expressing cells, in patients with recurrent World Health Organization (WHO) grade IV malignant glioma.
    • LINK
  • MRE Scan for the Assessment of Differences in Tissue Stiffness Between Radiation Necrosis and Recurrent Glioma in Patients With Previously Treated Gliomas
    • Brief Description: This trial uses magnetic resonance elastography (MRE) to estimate tissue stiffness (hardness or softness of the tissue) in tissue that is affected by radiation treatment (radiation necrosis) and tumor tissue that has come back (recurrent) after treatment in patients with gliomas. Diagnostic procedures, such as MRE, may estimate the differences in tissue stiffness between radiation necrosis and recurrent glioma post-treatment and ultimately lead to a more accurate diagnosis and/or surgery, and/or a better assessment of the disease’s response to treatment.
    • LINK
  • GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma (DMG)
    • Brief Description: This phase I study is to test whether GD2-CAR T cells can be successfully made from immune cells collected from children and young adults with H3K27M-mutant diffuse intrinsic pontine glioma (DIPG) or spinal H3K27M-mutant diffuse midline glioma (DMG). H3K27Mmutant testing will occur as part of standard of care prior to enrollment.
    • LINK
  • Convection-enhanced delivery of MTX110 Newly Diagnosed Diffuse Midline Gliomas
    • Brief Description: The purpose of this phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive an infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days.
    • LINK
  • Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (JAZZ)
    • Brief Description: This phase II trial studies the side effects of solriamfetol in improving sleep in patients with grade II-IV glioma. Solriamfetol is a wakefulness-promoting drug. Giving solriamfetol may improve sleep, memory, fatigue, mood, or quality of life in patients with brain tumors (gliomas).
    • LINK
  • INCMGA00012 and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas
    • Brief Description: In this phase II study, the investigators propose to combine INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). The investigators hypothesize that this combination provides a powerful synergy between RT and immune modulators to produce a more robust anti-tumor immune response, induce tumor regression, and improve overall survival.
    • LINK
  • Infigratinib in Recurrent Glioblastoma Patients
    • Brief Description: This trial is an open-label, multicenter, phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor.
    • LINK
  • Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MPP2+ Recurrent or Progressive Glioblastoma
    • Brief Description: This phase I trial studies the side effects and best dose of chimeric antigen receptor (CAR) T cells with a chlorotoxin tumor-targeting domain in treating patients with MPP2+ glioblastoma that has come back (recurrent) or that is growing, spreading, or getting worse (progressive). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
    • LINK
  • LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients
    • Brief Description: This trial is an open-label, multicenter, Phase 0/II trial that will enroll up to 50 participants with recurrent glioblastoma which are scheduled for resection.
    • LINK
  • BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations
    • Brief Description: This phase I/II trial studies the side effects and how well BGB-290 and temozolomide work in treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back.
    • LINK
  • INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas
    • Brief Description: This is a multicenter phase I trial of INCB7839 for children with recurrent or progressive high-grade gliomas, including, but not limited to, diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), after upfront therapy.
    • LINK
  • Ivosidenib in Treating Patients With Advanced Solid Tumors, Including Some Pediatric Brain Tumors, With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
    • Brief Description: This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors that have spread to other places in the body (advanced), lymphoma, or histiocytic disorders that have IDH1 genetic alterations (mutations).
    • LINK
  • Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma
    • Brief Description: The purpose of this small pilot study is to establish the safety of infusions of panobinostat (MTX110) into the fourth ventricle of the brain or tumor resection cavity in patients with recurrent medulloblastoma and to assess the antitumor activity of simultaneous infusions of panobinostat (MTX110) into the fourth ventricle of the brain or resection cavity in patients with recurrent medulloblastoma based upon MRI scans and lumbar cerebrospinal fluid (CSF) cytology.
    • LINK
  • Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial, and Spinal Cord Ependymoma
    • Brief Description: A phase II study to see if marizomib stops tumor growth and prolongs the time that the tumor is controlled.
    • LINK
  • Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
    • Brief Description: This is a phase II study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second-line treatment and who have not previously received any BEV or any experimental agents.
    • LINK
  • FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
    • Brief Description: The purpose of this pilot study will be to conduct a clinical trial using a time-of-flight PET scanner and MRI scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients.
    • LINK
  • Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
    • Brief Description: This phase I trial studies the side effects and how well of pembrolizumab and a vaccine therapy (ATL-DC vaccine) work in treating patients with glioblastoma that has come back (recurrent) and can be removed by surgery (surgically accessible).
    • LINK
  • Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence
    • Brief Description: The purpose of this phase II study is to assess the clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.
    • LINK
  • Serial MRI Scans During Radiation Therapy (RELAY)
    • Brief Description: This is a phase I study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with glioblastoma. The research study procedures include three MRI scans (one pre-treatment, during and post standard care cancer radiation therapy) for participants with glioblastoma
    • LINK
  • Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors
    • Brief Description: The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that combines EGFR with TGFβ. Based on preclinical data, this dual-targeted, bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors, including glioblastoma.
    • LINK
  • Safety of ABM-1310 Monotherapy in Patients With Advanced Solid Tumors
    • Brief Description: This is a phase I, First-In-Human, open-label, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of ABM-1310 in patients, including those with glioblastoma.
    • LINK
  • Study of the Effect of GM-CSF on Macrophages in Ependymoma
    • Brief Description: This phase I study plans to learn more about the use of Granulocyte Macrophage Colony Stimulation Factor (GM-CSF) on ependymoma tumors. The use of GM-CSF is a potential way of increasing the infiltration of immune cells and this study is looking at whether or not this will improve the outcome of patients with an ependymoma.
    • LINK
  • A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
    • Brief Description: This phase III trial studies if selumetinib works as well as carboplatin and vincristine for getting rid of or shrinking low-grade gliomas and stopping them from coming back.
    • LINK
  • Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
    • Brief Description: This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill cancer cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment.
    • LINK
  • Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
    • Brief Description: This early phase I trial studies the feasibility of giving memantine for the reduction of cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors. Memantine may reduce the effects of radiation therapy on memory and thinking.
    • LINK
  • Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System
    • Brief Description: This trial studies the feasibility of using intensity-modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity-modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
    • LINK
  • Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors
    • Brief Description: This phase II study is to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy.
    • LINK

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.

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