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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001381 |
Purpose
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.
| Condition | Intervention | Phase |
|
Bladder Neoplasms Carcinoma, Transitional Cell |
Drug: suramin |
Phase I |
| Genetics Home Reference related topics: | bladder cancer |
| MedlinePlus related topics: | Bladder Cancer Cancer |
| Drug Information available for: | Suramin Suramin Hexasodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder |
| Estimated Enrollment: | 18 |
| Study Start Date: | March 1994 |
| Estimated Study Completion Date: | December 2000 |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 940098, 94-C-0098 |
| First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001381 |
| Health Authority: | United States: Federal Government |
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