Optune® + Bevacizumab in Bevacizumab-RR Glioblastoma

PHASE II TRIAL OF OPTUNE® PLUS BEVACIZUMAB IN BEVACIZUMAB-REFRACTORY RECURRENT GLIOBLASTOMA

February 21, 2018

  • Clinical Trial Information

    Trial Contact: Walton, Sherri

    Trial Phone: 321.841.1907

  • IRB No: 17.099.08

    Protocol Abbrev: RTOG 3503

    Principal Investigator: Nicholas G. Avgeropoulos, MD

    Sub Investigators: Ramakrishna, Naren MD; Ranjan, Surabhi MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: RTOG 3503

    Treatment: Bevacizumab, Optune®

    Applicable Disease Sites: Brain

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT02743078

  • Objective

    This phase II trial will investigate the efficacy and safety of the addition of Optune (Tumor Treating Fields or TTF Therapy) to bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma

  • Key Eligibility

    Age ≥ 22
    •   Histologically proven diagnosis of glioblastoma or other grade IV malignant glioma (including variants of glioblastoma ie, gliosarcoma, giant cell glioblastoma, etc.).
    •   Confirmation of tumor recurrence or progression on contrast MRI (with and without gadolinium contrast) as determined by RANO criteria within 14 days prior to registration for patients who did not have recent resection of their glioblastoma or only had a stereotactic biopsy
    •   Failure on bevacizumab (either as a monotherapy or a combination) as most recent regimen confirmed by tumor recurrence on MRI. The patient must have failed no more than one regimen of bevacizumab. The patient must not have received bevacizumab as an upfront treatment in newly diagnosed glioblastoma