Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

Inclusion Criteria: * Men and women, must be between ages 18-72 * Patients must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor suggestive of high-grade glioma * Surgical treatment within 4 weeks of the baseline MRI is indicated * Karnofsky Performance Score of 60 or higher * Patients must have a pathological diagnosis of high-grade (IV) malignant glioma * Patients must be willing to use a barrier method of contraception if fertile or if of childbearing potential for up to 2 years after wafer implantation and be counseled regarding the unknown, and potentially harmful, risks to the embryo or fetus while treated on this study Exclusion Criteria: * Patients who have had prior cytoreductive surgery for high-grade glioma (patients who have had a diagnostic stereotactic biopsy are eligible) * Patients with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan * Concomitant significant life-threatening disease from which the patient could reasonably be expected to die within the first 12 months of the study * Known hypersensitivity reactions to temozolomide, nitrosoureas or any components of the Gliadel wafer * Prior CNS radiotherapy * Patients who have received any prior chemotherapy for malignant glioma prior to the baseline evaluation or patients who are currently being treated with chemotherapeutic agents * Patients with fewer than 100,000 platelets per mm3 or fewer than 3,500 leukocytes per mm3 * Liver function tests greater than or equal to 2.5 times the upper limit of normal (transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase) * Serum creatinine equal to or greater than 1.5 times the upper limit of normal, blood urea nitrogen (BUN) equal to or greater than 2.5 times the upper limit of normal * Pregnancy, or lactating females or females of childbearing potential not employing adequate contraception * Participation in any other investigational protocol in the prior twelve months for any type of malignancy * Psychological, familial, sociological or geographical conditions which do not permit adequate medical follow-up and compliance with the study protocol