Trial Outcomes & Findings for Intravesical BCG Administration to Patients With Invasive Bladder Cancer (NCT NCT02365207)

NCT ID: NCT02365207

Last Updated: 2019-11-05

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: At cystectomy at 3-6 weeks after BCG treatment
• Results posted on: 2019-11-05

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Baseline characteristics by cohort

Measure	BCG Treatment of Invasive Bladder Cancer n=6 Participants 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
Age, Customized	63.5 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized White-non Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

BCG Treatment of Invasive Bladder Cancer

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	BCG Treatment of Invasive Bladder Cancer n=5 participants at risk 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
Surgical and medical procedures Abdominal fluid collection	40.0% 2/5 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	20.0% 1/5 • Number of events 1 • 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.
Renal and urinary disorders Acute renal failure	20.0% 1/5 • Number of events 1 • 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.

Other adverse events

Measure	BCG Treatment of Invasive Bladder Cancer n=5 participants at risk 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
Renal and urinary disorders Gross hematuria	40.0% 2/5 • Number of events 2 • 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.
Blood and lymphatic system disorders Exploratory laparotomy	20.0% 1/5 • Number of events 1 • 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.
Renal and urinary disorders Dysuria	20.0% 1/5 • Number of events 4 • 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.
Gastrointestinal disorders Abdominal cramps	20.0% 1/5 • Number of events 1 • 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.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • 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.

Additional Information

Robert Svatek

University of Texas Health San Antonio

Phone: 210-567-5676

Email: svatek@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place