NCT00006476

Suramin in Treating Patients With Recurrent Bladder Cancer

A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer. * Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients. OUTLINE: This is a dose escalation study. At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity. Patients are followed at 2-4 weeks. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	suramin
PROCEDURE	conventional surgery

Timeline

• Start date: 2000-10-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-06-26

Locations

1 site across 1 country: United Kingdom