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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Rapamycin 0.5mg 		Subject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days
  • Drug: Sirolimus
    Other names:
    • Rapamycin
    • Rapamune
Active Comparator
Rapamycin 2.0mg 		Subject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days
  • Drug: Sirolimus
    Other names:
    • Rapamycin
    • Rapamune
No Intervention
Control 		Subject will be apart of the control group and won't take the study drug being tested

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.