Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330707
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2006-05-26
Brief Title:
Combined Use of BCG and Interferon Alpha in Bladder Cancer
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 63 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None