Clinical Trial Finder

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

The patient population in this Phase II clinical trial will be patients with newly diagnosed high-grade glioma undergoing initial surgery. Patients will receive Surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy with concomitant daily temozolomide (75 mg/m2) followed by monthly temozolomide given at the same dose (75 mg/m2 per day for 21 days each month. Patients will have up to 8 wafers implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between Study Days 14 and 45 all patients will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin. Temozolomide will be administered concomitantly with radiation at a daily dose of 75 mg/m2 daily (7 days/week) and then beginning no later than 30 days following completion of radiation therapy on a 75 mg/m2 daily dose given 21 days out of each month for a total of up to 18 cycles.