A Phase II Study of 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