Bryostatin 1 Plus Cisplatin in Treating Patients With Metastatic or Unresectable Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus cisplatin in treating patients who have metastatic or unresectable cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: bryostatin 1
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Bryostatin-1 (NSC 339555) and Cisplatin in Advanced Malignancies|
|Study Start Date:||January 1998|
|Primary Completion Date:||November 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of bryostatin 1 in combination with cisplatin in patients with advanced malignancy. II. Determine the recommended phase II doses of bryostatin 1 and cisplatin in both a 21 day and 14 day course, based on toxicity, effect on protein kinase C activity, and pharmacokinetics, in this patient population. III. Determine the pharmacokinetics of bryostatin 1 in these patients. IV. Identify any objective tumor responses arising from treatment in these patients.
OUTLINE: This is a dose escalation study of bryostatin 1. Cohorts 1-7: Patients receive cisplatin IV over 1 hour on day 1 of the first course. Subsequent courses repeat every 21 days with bryostatin 1 IV over 24 hours on day 1 and cisplatin IV over 1 hour on day 2 in the absence of disease progression or unacceptable toxicity. Cohorts 8-10: Patients receive cisplatin as in cohorts 1-7. Subsequent courses repeat every 21 days with bryostatin 1 IV over 1 hour followed by cisplatin on day 1. Cohort 11: Patients receive bryostatin 1 and cisplatin as in cohorts 8-10. Cohorts of 3-6 patients receive escalating doses of bryostatin 1 or cisplatin until the maximum tolerated dose (MTD) of is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. The recommended phase II dose (RPTD) is defined as the dose preceding the MTD. After the RPTD is determined for the 21 day schedule, cohorts of patients receive escalating doses of bryostatin and constant doses of cisplatin on a 14 day schedule. The MTD14 and RPTD14 are determined in the same manner as above. Patients are followed for 6 months.
PROJECTED ACCRUAL: A total of 36-72 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003132
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Franco M. Muggia, MD||New York University School of Medicine|