A Phase I Study of Bryostatin and Cisplatin in Patients With Advanced Cancer
OBJECTIVES: I. Determine the dose limiting toxicity and maximum tolerated dose of
combination bryostatin 1 and cisplatin chemotherapy in patients with advanced, incurable
OUTLINE: This is a dose-escalation study. The first 4 cohorts of patients receive an
escalating dose of cisplatin with a fixed dose of bryostatin 1, followed by 5 cohorts
receiving an escalating dose of bryostatin 1 and a fixed dose of cisplatin. In the first
course, cisplatin is given as a 2 hour infusion followed by a 24 hour continuous infusion of
bryostatin 1. In all subsequent courses bryostatin 1 is given first and cisplatin
afterwards. Treatment continues every 21 days in patients with stable or responding disease.
Dose escalation proceeds until the maximum tolerated dose (MTD) of the combination
chemotherapy is determined. The MTD is defined as the dose preceding that at which 2 or more
patients experience dose limiting toxicity. After the MTD is determined, an additional 10
patients are treated at this dose level. Patients are followed at 1 month.
PROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study.
Primary Purpose: Treatment
John L. Marshall, MD
Lombardi Cancer Research Center
United States: Federal Government
|Lombardi Cancer Center||Washington, District of Columbia 20007|