Clinical Trial Details
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NCT02152982 : Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
PhasePhase 2/Phase 3
AgesMin: 18 Years Max: N/A
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

- Sufficient tissue available for central pathology review and MGMT methylation status

- Patients who have had a local MGMT testing that is unmethylated are not allowed to

- 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

- Platelets >= 100,000 cells/mm^3

- Creatinine =< 1.5 x upper limit of normal (ULN)

- Bilirubin =< 1.5 x ULN; unless patient has Gilbert's disease

- Alanine aminotransferase (ALT) =< 3 x ULN

- Aspartate aminotransferase (AST) =< 3 x ULN

- 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

- 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,
biologics, immunotherapy, radiation therapy, or Novo-TTF-100A System

- 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: 1) has
not undergone a hysterectomy or bilateral oophorectomy; or 2) 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:

- Seizure disorder that is uncontrolled at the time of registration; the
definition of controlled seizures is patients must be without seizures for at
least 10 days prior to registration

- 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
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