Bladder Cancer
Conditions
Brief 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.
Detailed description
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.
Interventions
Intravesical instillation for non-muscle invasive bladder cancer
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCG response | 3 months after baseline | Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PPD conversion | 3 months from BCG vaccination | PPD conversion from negative to positive (defined as ≥ 10 mm induration at 48-72 hours following PPD placement). |
Countries
United States
Outcome results
None listed