Temozolomide with or without Veliparib in Treating Patients with Newly Diagnosed Glioblastoma Multiforme

Inclusion Criteria

• Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status
• Sufficient tissue available for central pathology review and MGMT methylation status evaluation
• Patients who have had a local MGMT testing that is unmethylated are not allowed to participate
• Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson
• Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma
• Absolute neutrophil count (ANC) >= 1500 cells/mm^3 (within 14 days prior to study registration)
• Platelets >= 100,000 cells/mm^3 (within 14 days prior to study registration)
• Creatinine =< 1.5 x upper limit of normal (ULN) (within 14 days prior to study registration)
• Bilirubin =< 1.5 x ULN (within 14 days prior to study registration; unless patient has Gilbert’s disease)
• Alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to study registration)
• Aspartate aminotransferase (AST) =< 3 x ULN (within 14 days prior to study registration)
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are eligible
• Progression: patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible; patients deemed to have pseudoprogression are eligible
• Prior treatment: * Must have completed standard radiotherapy and concomitant TMZ therapy as defined and determined by the study oncologist * Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or adjuvant) can be given prior to study registration, including chemotherapy (also including Gliadel/carmustine [BCNU] wafers), biologics, immunotherapy, radiation therapy; the only exception is the Optune device (NovoTTF-100A), which may be started any time after end of radiation therapy up through the initiation of Cycle 1; intent to use Optune must be declared at registration for stratification * No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
• Not pregnant and not nursing; females of childbearing potential must have negative urine or serum pregnancy test within 7 days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
• Comorbid conditions: patients are unable to participate due to the following: * Generalized or partial seizure disorder that is uncontrolled at the time of registration; the definition of controlled generalized seizures is patients must be on a stable dose of anti-seizure medication and without generalized seizures for at least 10 days prior to registration; the definition of controlled partial seizures is patients must be on a stable dose of anti-seizure medication for at least 10 days prior to registration; patients with occasional breakthrough partial seizures are allowed at treating physician’s discretion * Grade 3 or 4 thromboembolic disease within 6 months (mo) of registration * Known history of prolonged QT syndrome
• No history of major surgery =< 14 days prior to registration
• Patients must have adequate organ and marrow function measured within 28 days prior to administration of ABT-888 as defined below: * >= 10.0 g/dL hemoglobin (Hb) with no blood transfusion in the past 28 days
• No Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS