Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas

This is an interventional treatment trial for Acoustic Schwannoma Read More

Criteria

• Histologically proven recurrent or progressive intracranial meningioma; this includes benign, atypical, or malignant meningioma who may or may not have neurofibromatosis type 1 or 2; pathology can be from initial surgery; OR histologically proven intracranial hemangiopericytoma, hemangioblastoma (with or without metastatic disease), acoustic neuroma, or intracranial schwannoma
• Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is contraindicated); the scan must be performed within 14 days of registration
• Steroid dosing- must be on stable dose for at least 5 days prior to baseline imaging (Steroids are not required at the time of baseline imaging)
• Recent resection for recurrent tumor - patients will be eligible as long as they are greater than four weeks from surgery, have recovered from the effects of surgery, and have residual disease that can be evaluated; to best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively; if the 96 hour scan is more than 14 days before registration, it should be repeated
• Prior radiation therapy - patients may have been treated with standard external beam radiation or radiosurgery in any combination; an interval of >= 8 weeks (56 days) must have elapsed from the completion of radiation therapy to study entry and there must be subsequent evidence of tumor progression
• Patients with prior stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR spectroscopy or surgical documentation of disease
• Prior therapy: there is no limitation on the number of prior surgeries, radiation therapy, radiosurgery treatments, or chemotherapy agents
• Prior surgery: must be > 4 weeks from surgery
• Prior radiation: must be 8 weeks from end of treatment
• Prior chemotherapy: must be at least 4 weeks from cytotoxic therapy and 2 weeks from biologic therapies
• All patients must sign an informed consent indicating that they are aware of the investigational nature of the study
• Patients must sign an authorization for the release of their protected health information
• Karnofsky performance status >= 60%
• Absolute neutrophil count (ANC) >= 1,000/mm^3
• Platelets >= 100,000/mm^3
• Hemoglobin >= 8gm/dl
• Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x local laboratory upper limit of normal (ULN)
• Serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x local laboratory upper limit of normal (ULN)
• Creatinine =< 2.0 mg/dl
• PT, INR, and PTT =< 1.5 times institutional upper limits of normal
• Total serum bilirubin =< 1.5
• Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months
• No history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 5 years
• Patients may not have a history of prior treatment with inhibitors of the VEGF pathway (eg: VEGF trap, cediranib, vatalanib, sunitinib, sorafenib, etc.)
• No concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. QOL, are allowed
• No history of known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
• Anticoagulation with therapeutic warfarin (INR <3) and low molecular weight heparin is allowed
• Pregnancy or breast-feeding (Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate)
• Male patients must be surgically sterile or agree to use effective contraception; women of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to registration
• Patient must be able to comply with the study and follow-up procedures
• Life expectancy greater than 12 weeks
• Adequately controlled hypertension (defined as systolic blood pressure =< 150 mmHg and/or diastolic blood pressure =< 100 mmHg)
• No history of hypertensive crisis or hypertensive encephalopathy
• Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
• No history of myocardial infarction or unstable angina within 12 months prior to Day 1 of treatment
• No history of stroke or transient ischemic attack
• Patients must not have significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of treatment
• No history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 of treatment
• No evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• No history of 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
• No history of minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 of treatment
• No history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 of treatment
• Patients must not have serious non-healing wound, active ulcer, or unhealed bone fracture
• Urine protein:creatinine (UPC) ratio =< 1.0 at screening OR urine dipstick for proteinuria < 2 (patients discovered to have >= 2 proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible)
• No known hypersensitivity to any component of bevacizumab
• Patients may not have a prior history of bowel perforation