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| Sponsor: | Cancer Research UK |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006476 |
Purpose
RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: suramin Procedure: conventional surgery |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer |
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity.
Patients are followed at 2-4 weeks.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven recurrent superficial bladder cancer
Intermediate prognosis as defined by the following:
Previously treated superficial bladder cancer requiring followup cystoscopy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000068303, CRC-PHASE I/II-PH1/073, NCI-954 |
| Study First Received: | November 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006476 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer |
|
Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Suramin Urogenital Neoplasms Anthelmintics |
Urologic Neoplasms Pharmacologic Actions Neoplasms Antiparasitic Agents Neoplasms by Site Urologic Diseases Therapeutic Uses Antinematodal Agents |