Study ID: Alliance A071102
Randomized trial of veliparib or placebo in combination with adjuvant temozolomide in newly diagnosed GBM with MGMT promoter hypermethylation
This treatment trial is for patients who have been diagnosed with glioblastoma, a tumor that arises from astrocytes, which are the star-shaped cells that make up the “glue-like” or supportive tissue of the brain. This treatment trial seeks to determine if the chemotherapy drug temozolomide is more effective with or without the anti-cancer drug veliparib in treating glioblastoma.
Every patient will get the standard of care for glioblastoma, which is radiation and temozolomide. Additionally, there are two treatment arms in the study:
- One group of participants will take temozolomide orally once per day on days 1-5 and veliparib orally twice per day on days 1-7.
- The other group of participants will take temozolomide orally once per day on days 1-5 and a placebo orally on days 1-7.
For both groups, treatment repeats every 28 days for 6 courses as long as the participant’s disease does not progress or toxicity does not occur.
This randomized phase II/III trial seeks to determine how well temozolomide (TMZ) and veliparib work compared to TMZ alone in treating patients with newly diagnosed glioblastoma multiforme (GBM) with tumor MGMT promoter hypermethylation.
- Newly diagnosed WHO grade IV intracranial glioblastoma or gliosarcoma
- Sufficient tissue available for central pathology review and MGMT methylation status evaluation
- 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
- Patients who have had a local MGMT testing that is unmethylated
For the full list of inclusion/exclusion criteria, please see the clinicaltrials.gov website at the link below.
- Must have been newly diagnosed with glioblastoma
- Must be willing to take oral medications for the entire study time frame
- Must have completed standard radiotherapy and concomitant temozolomide therapy as defined and determined by the study oncologist