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Sponsors and Collaborators: |
National University Hospital, Singapore National Medical Research Council (NMRC), Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00330707 |
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 |
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Superficial Bladder Cancer |
Drug: Bacillus Calmette Guerin and interferon alpha |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre Randomised Controlled Double-Blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer |
Estimated Enrollment: | 140 |
Study Start Date: | October 1995 |
Estimated Study Completion Date: | June 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Singapore | |
National University Hospital | |
Singapore, Singapore, 119074 |
Principal Investigator: | Kesavan Esuvaranathan, FRCSEd MD | National University, Singapore |
Study ID Numbers: | NMRC/0085/1995 |
Study First Received: | May 26, 2006 |
Last Updated: | May 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00330707 |
Health Authority: | Singapore: Health Sciences Authority |
bladder cancer BCG interferon alpha |
Interferon-alpha BCG Vaccine Interferon Type I, Recombinant Cystocele Urinary Bladder Diseases Interferons Urinary Bladder Neoplasms |
Urogenital Neoplasms Urologic Neoplasms Urologic Diseases Interferon Alfa-2a Urinary tract neoplasm Bladder neoplasm |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |