Conditions: Glioma Astrocytoma Oligodendroglioma Glioblastoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 120
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression.

Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression

Protocol document: