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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   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes

November 3, 1999
March 3, 2008
March 1994
 
 
 
Complete list of historical versions of study NCT00001381 on ClinicalTrials.gov Archive Site
 
 
 
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder

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.

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.

Phase I
Interventional
Treatment, Safety Study
  • Bladder Neoplasms
  • Carcinoma, Transitional Cell
Drug: suramin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
18
December 2000
 

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.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001381
 
940098, 94-C-0098
National Cancer Institute (NCI)
 
 
National Institutes of Health Clinical Center (CC)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP