A Phase I Trial of Bizelesin (NSC 615291) Using a Single Bolus Infusion Given Every Twenty-eight (28) Days in Patients With Advanced Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of bizelesin in patients with advanced
cancer. II. Determine the qualitative and quantitative toxic effects of this therapy in
these patients. III. Determine the pharmacokinetics of this therapy in these patients. IV.
Determine the recommended dose of this drug for phase II trials. V. Determine the antitumor
effects of this therapy in these patients.
OUTLINE: This is a dose-escalation study. Patients receive bizelesin IV on day 1. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose (MTD)
is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients
experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Primary Purpose: Treatment
Eric K. Rowinsky, MD
University of Texas Health Science Center at San Antonio
United States: Federal Government
|Brooke Army Medical Center
|Fort Sam Houston, Texas 78234-6200
|Cancer Therapy & Research Center
|San Antonio, Texas 78229