Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma
- 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
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
Primary Purpose: Treatment
Susan M. Chang, MD
University of California, San Francisco
United States: Federal Government
|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|