PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
Completed · Early Phase 1
Conditions studied: Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT02326168
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 25
- Starts
- 2013-10-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-01-25
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The University of Texas Health Science Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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