Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.

Timeline

Start

2002-10

Primary completion

—

Completion

2010-09

Outcome

Missed primary endpoint

paper there was no clear survival benefit when comparing PCV with TMZ (hazard ratio [HR], 0.91; 95% CI, 0.74 to 1.11; P = .350). PMID 20855843 ↗

paper 12-week PFS rates were similar (63.6% and 65.7%, respectively; P = .745) PMID 20855843 ↗

Publications

• Results Brada M, Stenning S, Gabe R, Thompson LC, Levy D, Rampling R, Erridge S, Saran F, Gattamaneni R, Hopkins K, Beall S, Collins VP, Lee SM. Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. J Clin Oncol. 2010 Oct 20;28(30):4601-8. doi: 10.1200/JCO.2009.27.1932. Epub 2010 Sep 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lomustine	Small molecule	—	Oral
Subject	Temozolomide	Small molecule	100 mg/m2	Oral
Subject	Temozolomide	Small molecule	200 mg/m2	Oral
Subject	Vincristine	Small molecule	—	Intravenous
Subject	procarbazine	Small molecule	—	Oral

Indications