Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

Inclusion Criteria:

• Pathologic diagnosis of glioblastoma or grade IV glioma.
• Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
• Age > or = to 18
• KPS ≥70
• Granulocyte count >1.5 X 10 9/L
• Platelet count >99 X 10 9/L
• SGOT < 2.5X upper limit of normal (ULN)
• Serum creatinine < 2X ULN
• Bilirubin < 2X ULN
• All patients must sign written informed consent

Exclusion Criteria:

• Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
• Any prior experimental therapy for glioma.
• Multicentric glioma
• Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
• Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
• Pregnant or breast feeding women.
• Refusal to use effective contraception
• Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 12 months prior to Day 1
• History of stroke or transient ischemic attack
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
• History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
• Serious, non-healing wound, active ulcer, or untreated bone fracture
• Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
• Known hypersensitivity to any component of bevacizumab