Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

Exclusion Criteria

• •1. Stereotactic biopsy only (without further surgical resection)
• •2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
• •3. History, presence, or suspicion of metastatic disease
• •4. Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
• •5. Active systemic infection requiring treatment
• •6. History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.
• •7. Planned major surgery
• •8. Evidence of current drug or alcohol abuse
• •9. 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
• •10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
• •11. Women who are pregnant or lactating