A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
NCT ID: NCT02753309
Last Updated: 2021-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
33 participants
INTERVENTIONAL
2016-06-30
2021-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rapamycin 0.5mg
Subject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days
Sirolimus
Rapamycin 2.0mg
Subject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days
Sirolimus
Control
Subject will be apart of the control group and won't take the study drug being tested
No interventions assigned to this group
Interventions
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Sirolimus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Robert Svatek, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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HSC20160162H
Identifier Type: -
Identifier Source: org_study_id
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