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

Early Phase 1CompletedNCT02326168

The University of Texas Health Science Center at San Antonio25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months after baseline

Secondary Outcomes

PPD conversion

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