A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
- Determine the maximum tolerated dose of oral procarbazine when administered to patients
with recurrent glioma receiving or not receiving anticonvulsants metabolized by the
P450 hepatic enzyme complex.
- Determine the pharmacokinetics of oral procarbazine, including any effects of hepatic
enzyme inducing drugs, in these patients.
- Assess the response rate to procarbazine in these patients.
- Evaluate this regimen in terms of overall survival and duration of disease free
survival in these patients.
- Evaluate the toxicity of this regimen in these patients.
OUTLINE: Phase I of this study is a dose escalation study. Patients are stratified according
to concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or
- Phase I: Patients receive oral procarbazine once daily for 5 days. Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of oral procarbazine until the maximum
tolerated dose (MTD) is determined.
- Phase II: Once the MTD is determined, patients receive procarbazine as in Phase I.
Patients are followed every 2 months until death.
PROJECTED ACCRUAL: A total of 24-35 patients will be accrued for this study.
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|
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|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|
|Henry Ford Hospital||Detroit, Michigan 48202|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|