NCT00003021

Bizelesin in Treating Patients With Advanced Cancer

A Phase I Trial of Bizelesin (NSC 615291) Using a Single Bolus Infusion Given Every Twenty-eight (28) Days in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have advanced cancer.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	bizelesin

Timeline

• Start date: 1997-08-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2004-03-12
• Last updated: 2012-11-06

Locations

2 sites across 1 country: United States