Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma

Inclusion Criteria

• •Patients with histologically proven, non-progressive glioblastoma multiforme (GBM) or gliosarcoma (GS) with stable disease immediately following XRT + TMZ. All patients will receive Bevacizumab plus Tarceva and TMZ.
• •Biopsy or resection must have been performed prior to RT + TMZ.
• •No chemotherapy is allowed prior to starting RT + TMZ, including Gliadel Wafers.
• •Patients will have started RT + TMZ prior to registration and study entry and are eligible as long as they do not have progressive disease and can start Bevacizumab + TMZ and Tarceva within 4 weeks after the completion of RT + TMZ. Patients MUST have been treated with at least 54 Gy radiotherapy (60 Gy recommended) and MUST have received Temodar concurrently with radiotherapy for eligibility for this study.
• •Patients may or may not have measurable or evaluable disease on contrast MR imaging. A post-radiotherapy MRI scan must document stable disease.
• •Patients must be \> 18 years old and with a life expectancy \> 12 weeks.
• •Patients must have a Karnofsky performance status of ≥ 70.
• •Patients must have adequate bone marrow function (WBC \> 3,000/µl, ANC \> 1,500/mm3, platelet count of \> 100,000/mm3, and hemoglobin \> 10 mg/dl), adequate liver function (SGOT and bilirubin \< 1.5 times ULN), and adequate renal function (creatinine \< 1.5 mg/dL) before starting therapy. These tests must be performed within 14 days prior to initial treatment.