PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326168
• Other study ID #: 140005
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: January 23, 2017
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Bacillus Calmette-Guerin (BCG)
Intravesical instillation for non-muscle invasive bladder cancer

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after baseline
Secondary	PPD conversion	PPD conversion from negative to positive (defined as = 10 mm induration at 48-72 hours following PPD placement).	3 months from BCG vaccination