PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio