Suramin in Treating Patients With Recurrent Bladder Cancer

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

November 6, 2000
January 27, 2003
June 26, 2013
October 2000
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Complete list of historical versions of study NCT00006476 on Archive Site
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Suramin in Treating Patients With Recurrent Bladder Cancer
A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Bladder Cancer
  • Drug: suramin
  • Procedure: conventional surgery
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Ord JJ, Streeter E, Jones A, Le Monnier K, Cranston D, Crew J, Joel SP, Rogers MA, Banks RE, Roberts IS, Harris AL. Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer. 2005 Jun 20;92(12):2140-7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2007
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  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
CDR0000068303 ( Registry Identifier: PDQ (Physician Data Query) )
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Cancer Research UK
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Study Chair: Adrian L. Harris, MD Oxford University Hospitals NHS Trust
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP