A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage

Fecha de inicio: 1 de junio de 2007

Inclusion Criteria: * No evidence of bleeding diathesis or coagulopathy * Fertile patients must use effective contraception during and for \>= 2 months after completion of study therapy * No diarrhea \>= grade 1 * Histologically confirmed primary brain neoplasm, meningioma, or head and neck cancer \[WHO grade 2 or 3 disease--no WHO grade 4 primary brain neoplasms (i.e., glioblastoma or gliosarcoma)\] * Patients with head and neck cancer must not have any of the following: * Evidence of metastatic disease * Evidence of tumor invasion to major vessels (e.g., the carotid) * History of bleeding related to tumor or radiotherapy during or after completion of radiotherapy * Must have undergone cranial irradiation * Must have radiographic evidence to support the diagnosis of radiation necrosis and/or surgical biopsy evidence of necrosis without tumor within the past 2 months * Must have evidence of progressive neurologic signs or symptoms appropriate to the location of the radiation necrosis * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No significant traumatic injury within the past 28 days * No evidence of active CNS hemorrhage * Karnofsky performance status 60-100% * No clinically significant cardiovascular disease, including any of the following: * Inadequately controlled hypertension (i.e., systolic BP \> 140 mm Hg and/or diastolic BP \> 90 mm Hg despite antihypertensive medication) * Large vessel cerebrovascular accident within the past 6 months * Myocardial infarction or unstable angina within the past 6 months * No clinically significant cardiovascular disease, including any of the following: * NYHA class II-IV congestive heart failure * Serious or inadequately controlled cardiac arrhythmia * Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection) * Clinically significant peripheral vascular disease * At least 6 months since prior radiotherapy * Platelet count \> 75,000/mm\^3 * Granulocyte count \> 1,500/mm\^3 * Creatinine \< 1.0 times ULN * AST \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Prior chemotherapy for tumor allowed * Prior tyrosine kinase inhibitors of VEGF receptor (VEGFR) allowed * More than 28 days since prior and no concurrent major surgical procedure or open biopsy * Concurrent dexamethasone allowed provided patient is on a stable dose for \>= 1 week prior to study entry * Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided the following criteria are met: * In-range INR (usually between 2 and 3) and patient is on a stable dose of oral anticoagulant for 1 week or on a stable dose of low molecular weight heparin * No active bleeding or pathological condition that carries a high risk of bleeding * Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided the following criteria are met: No evidence of serious or nonhealing wound, ulcer, or bone fracture * No concurrent chemotherapy or tyrosine kinase inhibitors of VEGFR * No prior bevacizumab * More than 7 days since prior core biopsy * History of seizures allowed provided the patient is receiving anticonvulsant therapy * Hemoglobin \>= 9.0 g/dL * Bilirubin =\< 1.5 times upper limit of normal (ULN) * No other concurrent investigational agents