The Preston Robert Tisch Brain Tumor Center at Duke :: Pro00033396

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.