Back to resultsPRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bacillus Calmette-Guerin (BCG)
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
The patient must:
- Be 18 years of age or older
- Be able to give informed consent
- Have newly diagnosed or recurrent multi-focal Ta, Large Ta, High Grade Ta, CIS or T1 Bladder Cancer
- Determined by treating urologist to be a good candidate for BCG Induction Therapy
- Have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent
Exclusion Criteria:
The patient cannot:
- Be less than18 years of age
- Unable to give informed consent
- Have a history of muscle invasive bladder cancer
- Be self-reported to be immune-compromised (HIV, chronic immunomodulators, chronic corticosteroids)
- Have a history of tuberculosis and/or received BCG Percutaneous Vaccination
- Pregnant or planning to become pregnant.
Sites / Locations
- The University of Texas Health Science Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-muscle invasive bladder cancer
Arm Description
Every patient meeting eligibility criteria will receive a standard WHO adult potency Bacillus Calmette-Guerin (BCG) immunization (1cc/50mg live mycobacilli) in the right or left deltoid. Following a 19 - 31day wait period after BCG vaccination patients will then receive standard strength BCG intravesical therapy returning once a week for 6 consecutive weeks. Cystoscopy will be performed at 3 and 6 months. Interventions: BCG immunization in deltoid and BCG intravesical therapy once a week for 6 weeks.
Outcomes
Primary Outcome Measures
BCG response
Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder.
Secondary Outcome Measures
PPD conversion
PPD conversion from negative to positive (defined as ≥ 10 mm induration at 48-72 hours following PPD placement).
Full Information
NCT ID
NCT02326168
First Posted
December 5, 2014
Last Updated
January 23, 2017
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02326168
Brief Title
PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
Official Title
A Study Evaluating the Safety and Tolerability of Percutaneous Vaccination Prior to Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Mycobacteria for Non-Muscle Invasive Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.
Detailed Description
Approximately 25 subjects will receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-muscle invasive bladder cancer
Arm Type
Experimental
Arm Description
Every patient meeting eligibility criteria will receive a standard WHO adult potency Bacillus Calmette-Guerin (BCG) immunization (1cc/50mg live mycobacilli) in the right or left deltoid. Following a 19 - 31day wait period after BCG vaccination patients will then receive standard strength BCG intravesical therapy returning once a week for 6 consecutive weeks. Cystoscopy will be performed at 3 and 6 months.
Interventions: BCG immunization in deltoid and BCG intravesical therapy once a week for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Bacillus Calmette-Guerin (BCG)
Other Intervention Name(s)
Tice BCG
Intervention Description
Intravesical instillation for non-muscle invasive bladder cancer
Primary Outcome Measure Information:
Title
BCG response
Description
Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder.
Time Frame
3 months after baseline
Secondary Outcome Measure Information:
Title
PPD conversion
Description
PPD conversion from negative to positive (defined as ≥ 10 mm induration at 48-72 hours following PPD placement).
Time Frame
3 months from BCG vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The patient must:
Be 18 years of age or older
Be able to give informed consent
Have newly diagnosed or recurrent multi-focal Ta, Large Ta, High Grade Ta, CIS or T1 Bladder Cancer
Determined by treating urologist to be a good candidate for BCG Induction Therapy
Have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent
Exclusion Criteria:
The patient cannot:
Be less than18 years of age
Unable to give informed consent
Have a history of muscle invasive bladder cancer
Be self-reported to be immune-compromised (HIV, chronic immunomodulators, chronic corticosteroids)
Have a history of tuberculosis and/or received BCG Percutaneous Vaccination
Pregnant or planning to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Svatek, MD
Organizational Affiliation
Unv Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
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