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

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ClinicalTrials.gov Identifier: NCT00001381
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment Phase
Bladder Neoplasms Carcinoma, Transitional Cell Drug: suramin Phase 1

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 Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Primary Purpose: Treatment
Official Title: A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Study Start Date : March 1994
Study Completion Date : December 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.


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)

Publications:
ClinicalTrials.gov Identifier: NCT00001381     History of Changes
Other Study ID Numbers: 940098
94-C-0098
First Posted: December 10, 2002    Key Record Dates
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