A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
- 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.
Primary Purpose: Treatment
Adrian L. Harris, MD
Oxford Radcliffe Hospital
United States: Federal Government