Expired Study
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San Antonio, Texas 78229


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02326168


Primary Contact:

Principal Investigator
Robert S Svatek, MD
Unv Texas Health Science Center San Antonio


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78229
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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