Bladder CancerEarly Phase 1NCT02753309
A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
A Early Phase 1 study testing Sirolimus 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
This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG. 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?
- Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 2 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
- In their treating physician's opinion is a good candidate for BCG therapy
- Be able to give informed consent
- Be age 18 or older
- Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
- Not have active, uncontrolled infections
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- Not be on agents known to alter rapamycin metabolism significantly
- Not have a reported history of liver disease (e.g. cirrhosis)
- Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.
- Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.
Who cannot join
- Have muscle-invasive (≥T2) bladder cancer
- Unable to give informed consent
- Age < 18
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
- Active, uncontrolled infections
- On agents known to alter rapamycin metabolism significantly
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- Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
- Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
- Individuals with a reported history of liver disease (e.g. cirrhosis)
- Individuals who are not a good candidate for BCG in their treating physician's opinion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Randomized Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.
Read the detailed description
This study will evaluate change from baseline in gamma-delta T cell numbers and function and Ag85 peptide-specific T cell responses following treatment.
- Conditions
- Bladder Cancer
- Being tested
- Sirolimus
- Keywords
- BCG, Rapamycin
- 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.
SirolimusDrug
Also called Rapamycin, Rapamune
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin 0.5mg | Active comparator | Subject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days Receives: Drug: Sirolimus |
| Rapamycin 2.0mg | Active comparator | Subject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days Receives: Drug: Sirolimus |
| Control | No intervention | Subject will be apart of the control group and won't take the study drug being tested |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in systemic (whole blood) gamma-delta T cells frequency
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Measured: 4 weeks and 3 months after therapy
Percentage change in systemic (whole blood) gamma-delta T cell proliferation in response to BCG-specific antigens
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Measured: 4 weeks and 3 months after therapy
Percentage change in systemic (whole blood) Ag85 peptide-specific CD4 and CD8 T lymphocytes measured using human IFN-gamma release.
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Measured: 4 weeks and 3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion1 Dec 2019
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Svatek, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753309
- Sponsor's protocol ID
- HSC20160162H
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2016
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ji N, Mukherjee N, Reyes RM, Gelfond J, Javors M, Meeks JJ, McConkey DJ, Shu ZJ, Ramamurthy C, Dennett R, Curiel TJ, Svatek RS. Rapamycin enhances BCG-specific gammadelta T cells during intravesical BCG therapy for non-muscle invasive bladder cancer: a randomized, double-blind study. J Immunother Cancer. 2021 Mar;9(3):e001941. doi: 10.1136/jitc-2020-001941.
PubMed 33653802
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02753309
- Acronym / sponsor ID
- HSC20160162H
- Conditions
- Bladder Cancer
- Keywords
- BCG, Rapamycin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.
Detailed description
This study will evaluate change from baseline in gamma-delta T cell numbers and function and Ag85 peptide-specific T cell responses following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapamycin 0.5mg | Active comparator | Drug: SirolimusSubject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days |
| Rapamycin 2.0mg | Active comparator | Drug: SirolimusSubject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days |
| Control | No intervention | –Subject will be apart of the control group and won't take the study drug being tested |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
- In their treating physician's opinion is a good candidate for BCG therapy
- Be able to give informed consent
- Be age 18 or older
- Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
Key exclusion criteria (10 listed)
- Have muscle-invasive (≥T2) bladder cancer
- Unable to give informed consent
- Age < 18
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
- Active, uncontrolled infections
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 |
|---|---|---|
| SirolimusAlso: Rapamycin, Rapamune | Drug | Rapamycin 0.5mg, Rapamycin 2.0mg |
Primary outcome
Percentage change in systemic (whole blood) gamma-delta T cells frequency
Time frame: 4 weeks and 3 months after therapy
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Percentage change in systemic (whole blood) gamma-delta T cell proliferation in response to BCG-specific antigens
Time frame: 4 weeks and 3 months after therapy
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Percentage change in systemic (whole blood) Ag85 peptide-specific CD4 and CD8 T lymphocytes measured using human IFN-gamma release.
Time frame: 4 weeks and 3 months after therapy
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 33653802Ji N, Mukherjee N, Reyes RM, Gelfond J, Javors M, Meeks JJ, McConkey DJ, Shu ZJ, Ramamurthy C, Dennett R, Curiel TJ, Svatek RS. Rapamycin enhances BCG-specific gammadelta T cells during intravesical BCG therapy for non-muscle invasive bladder cancer: a randomized, double-blind study. J Immunother Cancer. 2021 Mar;9(3):e001941. doi: 10.1136/jitc-2020-001941.
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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
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sirolimus 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 19 Mar 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage change in systemic (whole blood) gamma-delta T cells frequency (time frame: 4 weeks and 3 months after therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753309, which also lists 1 linked publication.
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 19 Mar 2021.