A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
- Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients
with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02)
- Determine the toxic effects of this regimen in these patients.
- Determine the objective response in patients treated with the established MTD of this
- Determine time to tumor progression and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are
stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2),
and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02)
Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by
irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, additional patients are accrued to receive carboplatin and irinotecan at the
recommended phase II dose. (Phase I closed to accrual as of 6/24/02)
After chemotherapy, all patients undergo radiotherapy.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will
be accrued for this study. (Phase I closed to accrual as of 6/24/02)
Primary Purpose: Treatment
Michael L. Gruber, MD
New York University School of Medicine
United States: Federal Government
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|