The Preston Robert Tisch Brain Tumor Center at Duke :: Pro00034085

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