Metronomic Temozolamide in Patients With Recurrent Glioblastoma
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.