Suramin in Treating Patients With Recurrent Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00006476
- Lead Sponsor
- Cancer Research UK
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom