Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy

Exclusion Criteria

• •Radiotherapy or chemotherapy within the last 4 weeks.
• •Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
• •Prior VEGF-based therapy
• •Any condition (medical, social, psychological), which would prevent adequate information and follow-up
• •Any other concurrent active malignancy, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
• •Any significant cardiac disease (New York Heart Association Class II or greater), arrhythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris.
• •Clinically significant peripheral vascular disease
• •Evidence of bleeding diathesis, coagulopathy or taking ASA, NSAIDs or clopidogrel
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study
• •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
• •History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to day 0
• •History of known HIV, Hepatitis B and Hepatitis C negative
• •Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound, ulcer or bone fracture
• •Pregnancy or breast feeding
• •Requires therapeutic anti-coagulation
• •Blood pressure \> 150/100 mmHG
• •Grade 2 or greater proteinuria