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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Bladder Cancer

Treatments: Drug: Bacillus Calmette-Guerin (BCG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02326168

140005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

non-muscle invasive bladder cancer

Experimental group

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.

Treatment:

Drug: Bacillus Calmette-Guerin (BCG)