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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 University Hospitals NHS Trust
  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 September 18, 2014