Phase I/II Study of Pyrazoloacridine (PZA) in Adults With Newly Diagnosed Glioblastoma Multiforme
- Determine the maximum tolerated dose, toxicity, and pharmacokinetics of
pyrazoloacridine in adults with newly diagnosed, supratentorial glioblastoma multiforme
treated with pyrazoloacridine followed by radiotherapy.
- Determine the response rate, duration of disease free survival, and survival of
patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
type of anticonvulsant (hepatic metabolic enzyme inducers vs hepatic metabolic enzyme
moderate inducers or noninducers).
Patients receive pyrazoloacridine (PZA) IV over 3 hours on day 1. Treatment repeats every 3
weeks for a maximum of 4 courses in the absence of disease progression or unacceptable
toxicity. Following completion of PZA treatment, patients undergo cranial irradiation 5 days
a week for 6 weeks.
Cohorts of 3 patients receive escalating doses of PZA until the maximum tolerated dose (MTD)
is determined. Additional patients receive PZA at the MTD.
Patients are followed monthly for survival.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for phase I and a total of 18-35
patients will be accrued for phase II of this study.
Primary Purpose: Treatment
Glenn J. Lesser, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|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