Metronomic Temozolamide in Patients With Recurrent Glioblastoma

Summary

Indication: Subjects with glioblastoma at first relapse after surgery, radiotherapy and first-line temozolomide (TMZ). Objectives: 1. Phase I endpoint: \- To determine the maximum tolerated dose (MTD) of CPT-11 administered on days 8 and 22 in combination with a fixed, continuous, and metronomic regimen of TMZ, given in 28-day cycles. 2. Phase II endpoints: Primary endpoint: Progression-free survival at 6 months. Secondary endpoints: Response rate, toxicity profile, overall survival. Complementary studies: To assess the effect of treatment on plasma concentration of thrombospondin-1 (TSP1), soluble VEGF receptor 1 (sVEGF-1) and VEGF-A, and their correlation with clinical outcome. * To assess the correlation between immunohistochemical expression of PTEN and MGMT proteins, and clinical outcomes.

Timeline

Start

2007-11

Primary completion

2012-06

Completion

2012-06

Drugs

Indications