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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Progression-free survival as determined by Kaplan-Meier method.
Time frame: 6 months
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