Status:
COMPLETED
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Bladder Neoplasms
Carcinoma, Transitional Cell
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion ...
Detailed Description
Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion ...
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion.
Clinically useful pretreatment bladder function required.
No significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying.
No active urinary tract infection.
PRIOR/CONCURRENT THERAPY:
At least 1 course of prior standard intravesical therapy required.
At least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0 or 1.
Hematopoietic:
WBC at least 3,300;
Hemoglobin at least 10 g/dL.
Hepatic:
Bilirubin no greater than 1.5 mg/dL;
AST and ALT no greater than 2 times normal.
Renal: Creatinine no greater than 1.5 mg/dL.
OTHER:
Medically able to undergo cystoscopy.
No pregnant women.
Key Trial Info
Start Date :
March 1 1994
Trial Type :
INTERVENTIONAL
End Date :
December 1 2000
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00001381
Start Date
March 1 1994
End Date
December 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892