Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
- Determine the maximum tolerated dose of karenitecin in patients with recurrent
malignant glioma who are receiving or not receiving anticonvulsants known to be
metabolized by the P450 hepatic enzyme complex.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual
reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose associated with a dose-limiting toxicity rate of 33%.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Josephine Ford Cancer Center at Henry Ford Health System||Detroit, Michigan 48202|