Suramin in Treating Patients With Recurrent Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006476
First received: November 6, 2000
Last updated: June 25, 2013
Last verified: March 2007
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 15
Study Start Date: October 2000
Study Completion Date: October 2007
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • No clinically significant hepatic disease

Renal:

  • Creatinine clearance greater than 60 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy

Chemotherapy:

  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • No prior radiotherapy to the bladder
  • No concurrent radiotherapy

Surgery:

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

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006476

Locations
United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Adrian L. Harris, MD Oxford Radcliffe Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006476     History of Changes
Other Study ID Numbers: CRC-PHASE I/II-PH1/073, CDR0000068303, NCI-954
Study First Received: November 6, 2000
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Suramin
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on April 16, 2014