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

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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)

This Tabular View shows the required WHO registration data elements as marked by ^†

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.