Clinical trial NCT02326168: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bladder Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: BCG response
timeFrame: 3 months after baseline
Secondary outcomes:
measure: PPD conversion
timeFrame: 3 months from BCG vaccination
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Unv Texas Health Science Center San Antonio
name: Robert S Svatek, MD
role: PRINCIPAL_INVESTIGATOR
References: