Metronomic Temozolamide in Patients With Recurrent Glioblastoma

Sponsor
Grupo Español de Investigación en Neurooncología
Study ID
NCT01308632
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temozolamide, irinotecan — DRUG
    Phase I trial: TMZ will be administered in a fixed schedule as follows: TMZ 50 mg/m2/day divided in three daily doses (approx. 17 mg/m2/8 hours) on days 1-7, 9-21, and 23-28. 100 mg/m2 in a morning single dose on days 8 and 22 CPT-11 starting dose: 100 mg/m2 on days 8 and 22, administered 3 to 6 hours after TMZ. (Level 1) One cycle = 28 days CPT-11 will be escalated in successive cohorts of 3 patients as follows: 115, 130, 145, 160 mg/m2 .

Study Details

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.

Key Dates

Start date
Nov 30, 2007
Status verified
Mar 2011
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Temozolamide, irinotecan
    Phase I trial: TMZ will be administered in a fixed schedule as follows: TMZ 50 mg/m2/day divided in three daily doses (approx. 17 mg/m2/8 hours) on days 1-7, 9-21, and 23-28. 100 mg/m2 in a morning single dose on days 8 and 22 CPT-11 starting dose: 100 mg/m2 on days 8 and 22, administered 3 to 6 hours after TMZ. (Level 1) One cycle = 28 days CPT-11 will be escalated in successive cohorts of 3 patients as follows: 115, 130, 145, 160 mg/m2 .

Primary Outcome Measure

Efficacy of the treatment (Phase I) [ Time Frame: every patient should receive at least one cycle ( 28 days) ]

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