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

Summary

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.

Timeline

Start

2014-12-15

Primary completion

2021-12-01

Completion

2026-12-26

Publications

• Sarkaria JN, Ballman KV, Kizilbash SH, Sulman EP, Giannini C, Friday BB, Butowski NA, Mohile NA, Piccioni DE, Battiste JD, Drappatz J, Campian JL, Mashru S, Jaeckle KA, O'Brien BJ, Dixon JG, Kabat BF, Laack NL, Hu LS, Kaufmann T, Kumthekar P, Ellingson BM, Anderson SK, Galanis E. Efficacy of Adding Veliparib to Temozolomide for Patients With MGMT-Methylated Glioblastoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Dec 1;10(12):1637-1644. doi: 10.1001/jamaoncol.2024.4361.
• Gupta SK, Kizilbash SH, Carlson BL, Mladek AC, Boakye-Agyeman F, Bakken KK, Pokorny JL, Schroeder MA, Decker PA, Cen L, Eckel-Passow JE, Sarkar G, Ballman KV, Reid JM, Jenkins RB, Verhaak RG, Sulman EP, Kitange GJ, Sarkaria JN. Delineation of MGMT Hypermethylation as a Biomarker for Veliparib-Mediated Temozolomide-Sensitizing Therapy of Glioblastoma. J Natl Cancer Inst. 2015 Nov 27;108(5):djv369. doi: 10.1093/jnci/djv369. Print 2016 May.

Drugs

Indications