Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma
OBJECTIVES:
- Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug, in terms of survival and objective response, in
these patients.
OUTLINE: This is a dose-escalation study. Patients in phase II are stratified according to
use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type
(glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant
glioma). Patients in phase I must be currently receiving EIAEDs.
- Phase I: Patients receive CCI-779 IV over 30 minutes once weekly. Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CCI-779 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.
- Phase II: Patients receive CCI-779 as in Phase I. Patients who are candidates for
surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours
prior to surgery and then once weekly, as above, once recovered from surgery.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of this study within
12 months. A total of 87 patients will be accrued for phase II of this study within 12
months.
Interventional
Primary Purpose: Treatment
Susan M. Chang, MD
Study Chair
University of California, San Francisco
United States: Federal Government
CDR0000068848
NCT00022724
December 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |