PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | October 2015 |
A Study Evaluating the Safety and Tolerability of Percutaneous Vaccination Prior to Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Mycobacteria for Non-Muscle Invasive 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.
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.
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.
(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.
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.
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