Overview

The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)

Status:
Completed

Trial end date:
2009-09-15

Target enrollment:

Participant gender:

Summary

The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m^2).

Phase:

Phase 2

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.
Schering-Plough

Treatments:

Dacarbazine
Temozolomide