Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Glioblastoma, Gliosarcoma

In brief

This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.

Key facts

Study ID

NCT02152982

Run by

National Cancer Institute (NCI)

People needed

447

Starts

2014-12-15

Expected to finish

2026-12-26

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• John Muir Medical Center-Concord — Concord, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Fresno Cancer Center — Fresno, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Saint Jude Medical Center — Fullerton, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States
• Kaiser Permanente Oakland-Broadway — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States
• Kaiser Permanente-Redwood City — Redwood City, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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