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Suramin in Treating Patients With Recurrent Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00006476
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Bladder Cancer Drug: suramin Procedure: conventional surgery Phase 1

Detailed Description:


  • Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
  • Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Primary Purpose: Treatment
Official Title: A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
Study Start Date : October 2000
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven recurrent superficial bladder cancer

    • Intermediate prognosis as defined by the following:

      • Recurrent, multiple Ta, T1 carcinoma
      • Multiple (1-7) tumors
      • Tumors resected previously must be histological grade G1 or G2 OR
  • Previously treated superficial bladder cancer requiring followup cystoscopy

    • Recurrent disease diagnosed at surgery
  • No tumor invasion into muscle or carcinoma in situ



  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,500/mm3
  • Platelet count at least 150,000/mm3


  • No clinically significant hepatic disease


  • Creatinine clearance greater than 60 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • No history of adrenal insufficiency
  • No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No history of difficult catheterization
  • No confusion or disorientation
  • No other condition that would preclude study compliance


Biologic therapy:

  • No concurrent biologic therapy


  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids


  • No prior radiotherapy to the bladder
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior major thoracic or abdominal surgery


  • Recovered from prior therapy and stable for 4 weeks
  • At least 6 weeks since prior intravesicular therapy
  • No prior or concurrent investigational drugs
  • No concurrent anticoagulants

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): NCT00006476

United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Sponsors and Collaborators
Cancer Research UK
Study Chair: Adrian L. Harris, MD Oxford University Hospitals NHS Trust

ClinicalTrials.gov Identifier: NCT00006476     History of Changes
Other Study ID Numbers: CRC-PHASE I/II-PH1/073
CDR0000068303 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: March 2007

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antinematodal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents