Combined Use of BCG and Interferon Alpha in Bladder Cancer
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ClinicalTrials.gov Identifier: NCT00330707 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : March 4, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma of Urinary Bladder, Superficial | Drug: Bacillus Calmette Guerin and interferon alpha | Phase 2 Phase 3 |
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 |

- local toxicity
- systemic toxicity
- recurrence rate
- progression rate
- disease-specific mortality

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330707
Singapore | |
National University Hospital | |
Singapore, Singapore, 119074 |
Principal Investigator: | Kesavan Esuvaranathan, FRCSEd MD | National University, Singapore |
ClinicalTrials.gov Identifier: | NCT00330707 |
Other Study ID Numbers: |
NMRC/0085/1995 |
First Posted: | May 29, 2006 Key Record Dates |
Last Update Posted: | March 4, 2011 |
Last Verified: | March 2011 |
bladder cancer BCG interferon alpha |
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 |