Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder
Primary Purpose
Transitional Carcinoma of Urinary Bladder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BCG, Interferon
Sponsored by
About this trial
This is an interventional treatment trial for Transitional Carcinoma of Urinary Bladder
Eligibility Criteria
Inclusion Criteria:
- Patients with superficial transitional carcinoma of the urinary bladder
Sites / Locations
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00539773
First Posted
October 4, 2007
Last Updated
December 16, 2015
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00539773
Brief Title
Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder
Official Title
Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
5. Study Description
Brief Summary
Phase II Trial of concurrent administration of intravesical BCG & Interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Carcinoma of Urinary Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
BCG, Interferon
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
overall
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with superficial transitional carcinoma of the urinary bladder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shouki Bazarbashi, MD
Organizational Affiliation
King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder
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