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Poor accrual of subjects and lack of funding
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Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCG treatment of invasive bladder cancer | Experimental | Invasive bladder cancer treated with 3-6 weeks of intravesical BCG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG strain of Mycobacterium bovis | Drug | Invasive bladder cancer treated with 3-6 weeks of intravesical BCG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At cystectomy at 3-6 weeks after BCG treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Svatek, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MARC - The University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | At cystectomy at 3-6 weeks after BCG treatment |
|
Adverse events were collected during BCG administration at 3-6 weeks prior to cystectomy. Adverse events are only reported in the 5 subjects who received study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal fluid collection | Surgical and medical procedures | Non-systematic Assessment | Unanticipated: Subject was hospitalized with symptoms unrelated to study intervention: Abdominal fluid collection, body ache, chills, leg pain and surgical wound skin dehiscence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gross hematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Svatek | University of Texas Health San Antonio | 210-567-5676 | svatek@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2017 | Sep 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 5 |
| 3 |
| 5 |
| 5 |
| 5 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unanticipated: unrelated to study intervention (subject hospitalized post surgery) |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment | Unanticipated: related to surgical procedure, not study intervention |
|
| Exploratory laparotomy | Blood and lymphatic system disorders | Non-systematic Assessment | Unanticipated: unrelated to study drug: diagnosis of anemia prompted an exploratory laparotomy |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment | Painful and frequent urination which resolved within 24 hours |
|
| Abdominal cramps | Gastrointestinal disorders | Non-systematic Assessment | Abdominal cramps |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |