Among other criteria, patients must meet the following conditions to be eligible for the study:
- Age ≥18 years of age.
- Histologic diagnosis of glioblastoma (WHO Grade IV).
- Previous treatment for glioblastoma must include surgery,conventional radiation therapy and temozolomide (TMZ).
- First or second relapse of de novo glioblastoma.
- Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy.
- KPS of ≥ 70%.
- Life expectancy > 12 weeks.
- Documented EGFRvIII positive tumor status by a Sponsor designated laboratory.
- If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1.
- Evaluable disease
Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Subjects unable to undergo an MRI with contrast.
- History, presence, or suspicion of metastatic disease
- Prior receipt of vaccination against EGFRvIII.
- Any known contraindications to receipt of study drugs, including 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.
- Use of non-protein based investigational therapy within 14 days prior to Day 1 or use of antibody-based investigational therapy within 28 days prior to Day 1.
- Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Evidence of recent hemorrhage on screening MRI of the brain
- Evidence of current drug or alcohol abuse.