PHASE I-II TRIAL OF METRONOMIC TEMOZOLAMIDE WITH INTERMITTENT INTENSIFICATION AND IRINOTECAN IN PATIENTS WITH RECURRENT GLIOBLASTOMA

NCT01308632 Phase 2/Phase 3 UNKNOWN

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.

Details

Lead sponsor	Grupo Español de Investigación en Neurooncología
Phase	Phase 2/Phase 3
Status	UNKNOWN
Enrolment	30
Start date	2007-11
Completion	2012-06

Conditions

• Glioblastoma

Interventions

• Temozolamide, irinotecan

Primary outcomes

• Efficacy of the treatment (Phase I) — every patient should receive at least one cycle ( 28 days)
  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-days cycles to use the Recommended Dose in phase II
• Progression-free survival (Phase II) — Since the initial of the treatment until the patient progression
  The time the patient is not in progression, since the beginning of the treatment