NCT00392171

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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Glioma
• Astrocytoma
• Oligodendroglioma
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression

Timeline

• Start date: 2006-06-09
• Primary completion: 2009-09-15
• Completion: 2009-09-15
• First posted: 2006-10-25
• Last updated: 2017-06-07
• Results posted: 2010-05-17