Bladder CancerNCT02365207
Intravesical BCG Administration to Patients With Invasive Bladder Cancer
A study testing BCG strain of Mycobacterium bovis in people with Bladder Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- BCG strain of Mycobacterium bovis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have suspected or known invasive (≥T1) bladder cancer
- Be able to give informed consent
- Be age 18 or older
- Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Who cannot join
- Have non-invasive (<T1) bladder cancer
- Unable to give informed consent
- < 18 or older
- Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Trial locations and contacts
1 site in 1 country.
United States1 site
MARC - The University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- BCG strain of Mycobacterium bovis
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG strain of Mycobacterium bovisDrug
Also called BCG
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
| Study group | Role | What they receive |
|---|---|---|
| BCG treatment of invasive bladder cancer | Experimental | Invasive bladder cancer treated with 3-6 weeks of intravesical BCG Receives: Drug: BCG strain of Mycobacterium bovis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At cystectomy at 3-6 weeks after BCG treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startNov 2013
- Primary completion30 Sep 2018
- Study completion25 Apr 2019
Why it stopped: Poor accrual of subjects and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Svatek, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365207
- Sponsor's protocol ID
- 14-002
- Status last verified
- Sep 2018
- First submitted
- 3 Feb 2015
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02365207
- Acronym / sponsor ID
- 14-002
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual of subjects and lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Posted 5 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCG treatment of invasive bladder cancer | Experimental | Drug: BCG strain of Mycobacterium bovisInvasive bladder cancer treated with 3-6 weeks of intravesical BCG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have suspected or known invasive (≥T1) bladder cancer
- Be able to give informed consent
- Be age 18 or older
- Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Key exclusion criteria (4 listed)
- Have non-invasive (<T1) bladder cancer
- Unable to give informed consent
- < 18 or older
- Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG strain of Mycobacterium bovisAlso: BCGInvasive bladder cancer treated with 3-6 weeks of intravesical BCG | Drug | BCG treatment of invasive bladder cancer |
Primary outcome
Ability of BCG to Enhance Tumor Specific Immunity
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Svatek, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG strain of Mycobacterium bovis in people with Bladder Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of BCG to Enhance Tumor Specific Immunity (time frame: At cystectomy at 3-6 weeks after BCG treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.