Conditions: Glioblastoma Multiforme Astrocytoma
Keywords: Open label Imatinib mesylate hydroxyurea temozolomide resistant protein tyrosine kinases adenocarcinoma glioblastoma multiforme astrocytoma brain tumor brain cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief summary:
This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.

Detailed description:

Arms:
arm 1: Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening. arm 2: 1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.

Interventions: intervention 1: Imatinib mesylate intervention 2: Hydroxyurea
Intervention descriptions: intervention 1: Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles. intervention 2: None

Protocol document: