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Metronomic Temozolamide in Patients With Recurrent Glioblastoma

NCT01308632 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-03-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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 .

Sponsors & Collaborators

  • Grupo Español de Investigación en Neurooncología

    lead OTHER

Principal Investigators

  • Reynés Gaspar, Dr · Hospital Universitario La Fe de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308632 on ClinicalTrials.gov