A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

• Status: Completed
• Trial end date: 2021-03-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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