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A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder

This study has been completed.
Study NCT00001381.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Official Title  A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
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 will be evaluated.

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 will be evaluated.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bladder Neoplasms
Carcinoma, Transitional Cell
Intervention  Drug: suramin
MEDLINE PMIDs 1512858,   8738403,   7933214
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  18
Start Date  March 1994
Completion Date December 2000
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.

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001381
Organization ID 940098
Secondary IDs †† 94-C-0098
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date January 2000
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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