Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003108
• Lead Sponsor: Lombardi Comprehensive Cancer Center

Brief Summary

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 cisplatin plus bryostatin 1 in treating patients who have advanced cancer.

Detailed Description

OBJECTIVES: I. Determine the dose limiting toxicity and maximum tolerated dose of combination bryostatin 1 and cisplatin chemotherapy in patients with advanced, incurable solid tumors.

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.

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-02-06
• Study First Posted: 2004-02-09
• Status Verified: 2004-07
• Study Completion: 2007-10
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States