Combined Use of BCG and Interferon Alpha in Bladder Cancer

• ClinicalTrials.gov Identifier: NCT00330707
• Recruitment Status: Completed
• First Posted: May 29, 2006
• Last Update Posted: March 4, 2011
• Sponsor: National University Hospital, Singapore
• Collaborator: National Medical Research Council (NMRC), Singapore
• Information provided by: National University Hospital, Singapore

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Carcinoma of Urinary Bladder, Superficial	Drug: Bacillus Calmette Guerin and interferon alpha	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer
• Study Start Date: October 1995
• Study Completion Date: June 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. local toxicity
2. systemic toxicity
3. recurrence rate
4. progression rate
5. disease-specific mortality

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chiong E, Kesavan A, Mahendran R, Chan YH, Sng JH, Lim YK, Kamaraj R, Tan TM, Esuvaranathan K. NRAMP1 and hGPX1 gene polymorphism and response to bacillus Calmette-Guérin therapy for bladder cancer. Eur Urol. 2011 Mar;59(3):430-7. doi: 10.1016/j.eururo.2010.11.031. Epub 2010 Dec 1.

• ClinicalTrials.gov Identifier: NCT00330707
• Other Study ID Numbers: NMRC/0085/1995
• First Posted: May 29, 2006
• Last Update Posted: March 4, 2011
• Last Verified: March 2011

Keywords provided by National University Hospital, Singapore:

bladder cancer; BCG; interferon alpha

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Interferons; Interferon-alpha; BCG Vaccine; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs; Adjuvants, Immunologic