Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme

Exclusion Criteria

• •Prior toxicity grade ≥ 3 with TMZ
• •Prior treatment with bevacizumab
• •Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
• •Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• •Acute or chronic liver disease (i.e., hepatitis, cirrhosis)
• •Confirmed diagnosis of HIV infection
• •Have received investigational drugs less than 4 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy
• •Have received chemotherapy within 2 weeks prior (6 weeks for nitrosourea) to entry on this study, or who have not recovered from the toxic effects of such therapy
• •Have received biologic, immunotherapeutic or cytostatic agents within 1 week prior to entry on this study or who have not recovered from the toxic effects of such therapy
• •Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant
• •Have received radiation therapy within 2 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.
• •Surgical resection of brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
• •Have had any surgery other than resection of a brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
• •Unwilling to or unable to comply with the protocol
• •Evidence of tumor progression within on immediate post radiation brain imaging
• •Have not received at least 2 cycles of adjuvant chemotherapy
• •Life expectancy of less than 12 weeks
• •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
• •Bevacizumab-Specific Exclusions:
• •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 (see Appendix E)
• •History of myocardial infarction or unstable angina within 6 months
• •History of stroke or transient ischemic attack within 6 months
• •Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months
• •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 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
• •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 greater than or equal to 1.0 at screening
• •Known hypersensitivity to any component of bevacizumab