A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
Completed · Early Phase 1
Conditions studied: Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT02753309
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 33
- Starts
- 2016-06-01
- Expected to finish
- 2021-03-02
- Last updated by the study team
- 2021-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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.
You may not qualify if…
- 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
- 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
Where it is running
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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