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 (P04601AM1)(COMPLETED)
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma|
- Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Progression-free survival as determined by Kaplan-Meier method.
|Study Start Date:||June 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression
Other Name: SCH 52365