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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

National Cancer Institute (NCI)

Bethesda, Maryland, United States, 20892