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A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
This study has been completed.
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes
Sponsor: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 18
Study Start Date: March 1994
Estimated Study Completion Date: December 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001381

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
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

Keywords provided by National Institutes of Health Clinical Center (CC):
Adult
Intravesical Chemotherapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009