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

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.

Timeline

Start

2013-10

Primary completion

2015-10

Completion

2015-10

Drugs

Indications