The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials for Adults | An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide/TMZ in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Eligibility: Key Criteria

  • Histologically confirmed, newly diagnosed glioblastoma
  • EGFRvIII positive
  • Steroid dose must be < 2mg per day for at least 3 days prior to randomization
  • Patients must have had resection (biopsy only, not eligible)
  • 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
  • No previous therapy for glioblastoma, aside from surgical resection and chemoradiation with temozolomide

Study Design: Key Features

  • (n=440) following standard chemoradiation patients will be randomized into 1 of 2 arms
  • Arm A:  patients will receive Rindopepimut/GM-CSF in combination with standard adjuvant Temozolomide
  • Arm B:  patients will receive KLH in combination with standard adjuvant Temozolomide
  • Vaccine Priming Phase:  Beginning 7-14 days after completion of standard chemoradiation therapy, patients will receive two priming doses of (Rindopepimut or KLH )vaccine via intradermal injection, two weeks apart (on Priming Days 1 and 15).
  • Adjuvant Temozolomide/Vaccine Phase(TMZ-V):  TMZ will begin no sooner than 28 days after completion of concomitant Temozolomide radiation therapy, and will be dosed on days 1-5 of repeated 28 day cycles. TMZ will be dosed at 150mg/m² per day for the first cycle, then increased to 200mg/m² per day in subsequent TMZ cycles for a minimum of 6 cycles.
  • Vaccine Maintenance Therapy (VMT):  Following completion or discontinuation of TMZ for reasons other than tumor progression, double-blind vaccine maintenance therapy (VMT) will begin with the first VMT dose 28 days (+ 3 days) after last vaccination administered during TMZ phase. Double-blind vaccine will continue monthly (Day 1 + 3 days) of each 28 day cycle) until intolerance or tumor progression.
  • Cycles are 28 days long
  • MRI required every 8 weeks
  • Vaccine is provided by the sponsor
  • Temozolomide is NOT provided by the sponsor

Schedule of Requirements:

  • During Vaccine Priming Phase patients will return to Duke on days 1 and 15 for clinic visit, blood draws and to receive priming doses of vaccine.
  • During the Adjuvant Temozolomide/Vaccine Phase patients will return to Duke on days 1 and 22 (of a 28 day cycle).
  • During Vaccine Maintenance Therapy patients will return to clinic patients will return to clinic on day 1 of each 28 day cycle.

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