Combined Use of BCG and Interferon Alpha in Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00330707
First received: May 26, 2006
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer


Condition Intervention Phase
Carcinoma of Urinary Bladder, Superficial
Drug: Bacillus Calmette Guerin and interferon alpha
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • local toxicity
  • systemic toxicity
  • recurrence rate
  • progression rate
  • disease-specific mortality

Estimated Enrollment: 140
Study Start Date: October 1995
Estimated Study Completion Date: June 2005
Detailed Description:

140 eligible patients with high risk superifical bladder cancer would be randomised to receive standard dose BCG, low dose BCG or the combination of low dose BCG and interferon alpha in a schedule of "6+3" weekly intravesical instillations. Patients would be closely monitored with cystoscopy and urine cytology and intravenous urograms when indicated. Pre-and post-instillation urine samples would be collected for cytokine analysis.

  Eligibility

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

Inclusion Criteria:

(1) Patients must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who have received prior intravesical therapy other than BCG were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) There was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) Patients had a Karnofsky score >50. (6) Women of child?bearing age were using effective contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) All patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

  • (1) Patients with medical illness or mental status, which would preclude cooperation with the study. (2) Patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelial carcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) Patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) Patients who had been previously treated with intravesical BCG. (7) Patients with active tuberculosis.
  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: NCT00330707

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Kesavan Esuvaranathan, FRCSEd MD National University, Singapore
  More Information

No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00330707     History of Changes
Other Study ID Numbers: NMRC/0085/1995
Study First Received: May 26, 2006
Last Updated: March 2, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
bladder cancer
BCG
interferon alpha

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
BCG Vaccine
Interferon-alpha
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014