Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:
• Any intracranial high-grade glioma (phase I*)
• Glioblastoma or gliosarcoma (phase II*)
• Patients whose original histology was low-grade glioma are eligible provided they were subsequently diagnosed with glioblastoma or gliosarcoma
• Unequivocal radiographic evidence for tumor progression by MRI within 14 days prior to registration and with a stable or decreasing dose of steroids at least 5 days prior to scanning OR recent resection (registration within 30 days of resection) as long as all of the following conditions are met:
• Patients must have recovered from the effects of surgery
• Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative MRI scan should be performed within 28 days prior to registration and within 96 hours post surgery (although 24 hours would be optimum)
• Prior radiation is required for the phase I* arm
• Patients must have completed a course of radiation therapy and at least 2 consecutive adjuvant cycles of temozolomide (phase II*)
• A stable or decreasing dose of steroids at least 5 days prior to scanning is not mandated for patients who had a recent resection
• No evidence of acute (i.e., new and active) intratumoral hemorrhage on MRI
• Patients with MRI demonstrating old hemorrhage or subacute blood after a neurosurgical procedure (biopsy or resection) are eligible Note: *Phase I was closed and phase II was opened on 3/6/12.

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• White blood cell (WBC) count ≥ 3,000/mm^3
• Absolute neutrophil count (ANC) ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
• Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3.0 times upper limit of normal (ULN)
• Serum glutamic pyruvic transaminase (SGPT) ≤ 3.0 times ULN
• Bilirubin ≤ 1.25 times ULN
• Creatinine < 1.7 mg/dL OR estimated glomerular filtration rate (GFR) ≥ 30 mL/min
• Urine protein: creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection**
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
• Able to undergo brain MRI scans with IV gadolinium
• Able to swallow oral medications
• Patients with a history of seizure, or new onset of seizures, should be clinically controlled with no seizures for at least 14 days prior to registration
• No other prior invasive malignancy (except for nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease-free and off therapy for that disease for ≥ 3 years
• No severe, active comorbidity, including any of the following:
• Transmural myocardial infarction or unstable angina within the past 6 months
• Evidence of recent myocardial infarction or ischemia as indicated by S-T elevations of ≥ 2 mm on EKG performed within the past 14 days
• New York Heart Association (NYHA) class II-IV congestive heart failure requiring hospitalization within the past 12 months
• Stroke or transient ischemic attack within the past 6 months
• Cerebral vascular accident within the past 6 months
• Serious and inadequately controlled cardiac arrhythmia
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Serious non-healing would, ulcer, or bone fracture
• Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within the past 28 days
• Significant traumatic injury within the past 28 days
• Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 14 days
• AIDS based upon c