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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 |
| 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 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001381 History of Changes |
| Health Authority: | United States: Federal Government |
|
Adult Intravesical Chemotherapy |
|
Urinary Tract Neoplasm Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Suramin Anthelmintics Urogenital Neoplasms |
Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma Urologic Diseases Bladder Neoplasm Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
|
Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Suramin Anthelmintics Urogenital Neoplasms Carcinoma, Transitional Cell |
Urologic Neoplasms Pharmacologic Actions Carcinoma Antiparasitic Agents Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Neoplasms, Glandular and Epithelial Antinematodal Agents |