Bladder Cancer
Conditions
Brief summary
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
Detailed description
Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.
Interventions
DRUGBCG strain of Mycobacterium bovis
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Have suspected or known invasive (≥T1) bladder cancer 2. Be able to give informed consent 3. Be age 18 or older 4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)
Exclusion criteria
1. Have non-invasive (\<T1) bladder cancer 2. Unable to give informed consent 3. \< 18 or older 4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of BCG to Enhance Tumor Specific Immunity | At cystectomy at 3-6 weeks after BCG treatment | The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BCG Treatment of Invasive Bladder Cancer Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | BCG Treatment of Invasive Bladder Cancer |
|---|---|
| Age, Customized | 63.5 Years |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized White-non Hispanic | 3 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
Ability of BCG to Enhance Tumor Specific Immunity
The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10
Time frame: At cystectomy at 3-6 weeks after BCG treatment
Population: Data were not analyzed, since the study closed prematurely due to poor accrual and lack of funding. Since the change in T-cell proliferation required a sample size of at least 10 and only 4 subjects who were randomized completed. No data were analyzed for this study, since that sample size was not achieved.