cancer.duke.edu/btc  
The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials for Adults | A Phase II Study of Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma

Eligibility: Key Criteria

  • Histological diagnosis of glioblastoma
  • Previous treatment for glioblastoma must include surgery (biopsy, partial resection, or full surgical resection), conventional radiation therapy and Temozolomide
  • First or second relapse of primary glioblastoma
  • Resolution of all chemotherapy or radiation-related toxicities, except for alopecia and hematologic toxicity
  • KPS > 70
  • No history, presence or suspicion of metastatic disease
  • No known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins

Study Design:  Key Features

  • Patients will be placed in 1 of 2 cohorts
  • Cohort 1 (n=70)  Bevacizumab naïve patients will be randomized to 1 of 2 arms
  • Arm A: patients will receive Rindopepimut/GM-CSF in combination with Bevacizumab
  • Arm B: patients will receive control KLH in combination with Bevacizumab
  • Cohort 2 (n=25) patients who have previously failed Bevacizumab will receive Rindopepimut/GM-CSF in combination with Bevacizumab
  • Cycles are 28 days long
  • MRI required every 8 weeks
  • Vaccine is provided by the sponsor
  • Bevacizumab is NOT provided by sponsor

Schedule of Requirements:

  • Patients will initially come to Duke to receive 3 priming doses (vaccine or control KLH) on days 1, 15 and 29 and then monthly every 28 days
  • Standard of care Bevacizumab will be given intravenously every 2 weeks starting on study day 1


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