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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001381
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001381


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

Publications:
ClinicalTrials.gov Identifier: NCT00001381     History of Changes
Other Study ID Numbers: 940098
94-C-0098
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: January 2000

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Suramin
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents