Temozolomide + Veliparib for Glioblastoma

Recruiting at 446 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jann N Sarkaria

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for adults with newly diagnosed glioblastoma multiforme or gliosarcoma. Participants must have proper liver function, enough tissue for testing, and their tumor must not be a specific subtype (1p19q codeleted). They should also have normal blood cell counts and kidney function. Those with certain genetic features of the tumor that make it less likely to respond to treatment are excluded.

Inclusion Criteria

My brain tumor is confirmed as grade IV glioblastoma or gliosarcoma.

My condition hasn't worsened outside the treated area after chemoradiation.

I haven't received any treatment before this study except for TMZ with radiation and possibly the Optune device.

Exclusion Criteria

My GBM cancer has specific genetic features (1p19q codeleted).

I haven't had cancer in the last 5 years, except for skin cancer.

I have AML or MDS, possibly caused by previous treatments.

Treatment Details

Interventions

• Temozolomide (Alkylating agents)
• Veliparib (PARP Inhibitor)

Trial Overview The study is examining if adding Veliparib to Temozolomide chemotherapy improves outcomes in treating brain cancer compared to Temozolomide alone. It's a randomized trial, meaning patients are put into the two different treatment groups by chance.

Participant Groups

Group I: Arm I (temozolomide, veliparib) Experimental Treatment 4 Interventions

Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.

Group II: Arm II (temozolomide, placebo) Placebo Group 4 Interventions

Patients receive temozolomide as in Arm I and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+