NCT00330707

Combined Use of BCG and Interferon Alpha in Bladder Cancer

A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (planned)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Carcinoma of Urinary Bladder, Superficial

Interventions

Type	Name	Description
DRUG	Bacillus Calmette Guerin and interferon alpha

Timeline

• Start date: 1995-10-01
• Completion: 2005-06-01
• First posted: 2006-05-29
• Last updated: 2011-03-04

Locations

1 site across 1 country: Singapore