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NBTS Brain Tumor Clinical Trials Report – Q1 2019

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 the new opportunities available to consider potentially participating in as part of their treatment plan. This report provides a summary of clinical trials for primary brain tumor patients that have opened for enrollment in the U.S. since our last quarterly report. 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.

  • Phase 0/2 Trial of Ribociclib & Everolimus
    • Brief Description: In this early phase clinical trial, patients will be administered ribociclib+everolimus prior to surgical resection of their tumor. Recurrent GBM patients will be randomized into one of the three time-interval cohorts.
    • LINK:
  • Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma
    • Brief Description: This early phase clinical trial studies the side effects and how well ketoconazole works before surgery in treating patients with glioma that has come back or breast cancer that has spread to the brain. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.
    • LINK:
  • Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
    • Brief Description: The purpose of this phase II clinical trial is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), or biliary tract cancers (BTC). Participants will be enrolled into initial tumor-specific cohorts which will be expanded if adequate efficacy is determined.
    • LINK:
  • Dose Escalation Study of CLR 131 in Children and Adolescents With Relapsed or Refractory Malignant Brain Cancer, Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma
    • Brief Description: This phase I clinical trial evaluates CLR 131 in children and adolescents with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.
    • LINK:
  • Phase II Trial of Seizure Prophylaxis in Suspected Primary Glioma Patients Undergoing Craniotomy
    • Brief Description: A phase II clinical trial to assess the need for seizure prophylaxis in the perioperative period for patients undergoing craniotomy for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV). This will be determined by observing the impact of Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to the emergency department (ED) or hospital re-admissions occur within 30 days after craniotomy. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV. Exploratory endpoints will evaluate admission duration for the craniotomy, number of post-operative provider communications (telephone, email, and additional clinic encounters, etc.), and patient risk factors associated with postoperative seizure.
    • LINK:
  • Testing Ramipril to Prevent Memory Loss in People With Glioblastoma
    • Brief Description: A phase II clinical trial to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.
    • LINK:
  • Sunitinib in Sarcomas of the Central Nervous System
    • Brief Description: A phase II clinical trial to study the effects of Sunitinib on gliosarcomas.
    • LINK:
  • rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-lymphopenic Gliomas Following Radiation and Temzolomide
    • Brief Description: A phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG).
    • LINK:
  • A Study Utilizing Escitalopram in Glioma Patients
    • Brief Description: A phase II clinical trial that will include grade II and III glioma patients treated with SSRIs during a 3 month study period. Changes in cognition and evaluation of psychosocial factors from baseline to after three months of treatment with SSRI study drug will be calculated.
    • LINK:
  • Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption
    • Brief Description: The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2.0 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.
    • LINK:
  • Nivolumab in People With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
    • Brief Description: A phase II clinical trial to see if the drug nivolumab increases the time it takes for certain gliomas to get worse.
    • LINK:
  • 18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning For a Short Course of Proton Beam Radiation Therapy
    • Brief Description: This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.
    • LINK:
  • CART-EGFRvIII + Pembrolizumab in GBM
    • Brief Description: This is an open-label, phase 1 study to assess the safety and tolerability of EGFRvIII T cells in combination with pembrolizumab (PD-1 Inhibitor) in patients with newly diagnosed, EGFRvIII+, MGMT-unmethylated glioblastoma.
    • LINK:
  • Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma
    • Brief Description: A phase I clinical trial being done to test if it is safe to give nivolumab with targeted immunotherapy drugs for recurrent glioblastoma (GBM), a type of brain tumor. The study doctors believe that giving immunotherapy drugs that match the biomarkers in a tumor will help the immune system fight the tumor. Tumor tissue collected during surgery will be tested for certain biomarkers to determine which immunotherapy might best target the tumor.
    • LINK:
  • Oncolytic Adenovirus DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
    • Brief Description: This phase I trial studies the 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.
    • LINK:

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

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