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.