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

The University of Texas Health Science Center at San Antonio · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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bladder-cancer
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.
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