Vaccine Therapy with Bevacizumab or Bevacizumab Alone in Treating Patients with Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Inclusion Criteria

• PRE-REGISTRATION (PRE-SURGERY) ELIGIBILITY CRITERIA
• Prior histologic diagnosis of GBM or gliosarcoma at first occurrence
• First or second recurrence of GBM or gliosarcoma considered to be surgically resectable
• Prior treatment: * No radiotherapy within 90 days prior to pre-registration * No prior treatment with any anti-angiogenic agent targeting the vascular endothelial growth factor (VEGF) pathway including but not limited to bevacizumab, cediranib, vandetanib, sunitinib, pazopanib, aflibercept or sorafenib * No prior treatment with HSPPC-96 or other investigational immunotherapy * Must have received prior treatment with radiotherapy and temozolomide for histologically confirmed GBM at initial diagnosis * No tumor directed therapy for most recent progression * No prior Gliadel wafers
• No clinically significant cardiovascular disease * Patients with a history of hypertension must be well controlled (< 150/90) on a regimen of antihypertensive therapy * History of arterial thrombotic events within the past 6 months, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina, or angina requiring surgical or medial intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection) are not eligible * Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation * No current New York Heart Association classification II, III, or IV congestive heart failure
• No significant bleeding within the past 6 months; no bleeding diathesis or coagulopathy
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months
• No evidence of any systemic autoimmune disease (e.g. Hashimoto’s thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
• Karnofsky functional status rating >= 70
• No more than 16 mg dexamethasone (or equivalent) per day
• Non-pregnant and non-nursing
• REGISTRATION (POST-SURGERY) ELIGIBILITY CRITERIA
• Pre-registration eligibility criteria continue to be met
• Confirmed histological diagnosis of recurrent GBM or gliosarcoma
• >= 90% surgical resection of recurrent GBM confirmed by central radiology review by magnetic resonance imaging (MRI) with or without gadolinium per institutional guidelines; a computed tomography (CT) scan is allowable in place of MRI only in situations where an MRI is contraindicated (e.g., patient has a heart pacemaker, metallic devices in the eye, brain or spine, severe claustrophobia)
• Five grams of resected tumor available for vaccine manufacture as determined by institutional pathologist; seven grams of tumor is preferred
• Availability of >= 4 clinical vials of HSPPC-96
• Granulocytes >= 1,500/uL
• Platelet count >= 100,000/uL
• Total bilirubin =< 2.0 x upper limit of normal (ULN)
• Urine protein creatinine (UPC) ratio < 1 OR urine protein =< 1+
• Calculated creatinine clearance >= 45 ml/min
• Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) =< 2.5 x ULN
• No serious, non-healing wounds or ulcers
• At least 7 days since any minor surgery such as port placement
• No major surgical procedures, open biopsy or significant traumatic injury =< 28 days prior to registration or anticipation of need for elective or planned major surgical procedure during the study; core biopsy or other minor surgical procedures =< 7 days prior to registration
• No active or recent hemoptysis (>= 1/2 teaspoon of bright red blood per episode) =< 30 days prior to registration
• No new bleeding on day 28 (D28) (+/-3) MRI (or CT if MRI is contraindicated)
• No clinical deterioration at the time of registration/randomization
• If a second surgery is needed for completion of resection, this should be within 30 days from the first surgery