CCI-779 in Treating Patients With Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma.
Brain and Central Nervous System Tumors
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma|
|Study Start Date:||December 2001|
- 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.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-6220|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Susan M. Chang, MD||University of California, San Francisco|