Purpose

The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).

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 within 60 days prior to enrollment
  • 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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
When it is determined that you are eligible for the study, you will be assigned by chance (like flipping a coin) to one of 2 study groups. Sirolimus 0.5 mg/day for 2 years or until disease recurrence Placebo
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double-blinded for study staff (investigator) and patient

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo Oral Tablet
Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence
  • Drug: Placebo Oral Tablet
    Subject will be randomized to one of the 2 arms
Active Comparator
Sirolimus (Rapamycin) 0.5 mg/day for 2 years
Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence
  • Drug: Rapamycin
    Subject will be randomized to one of the 2 arms
    Other names:
    • Sirolimus

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Emily M Rios, BA
210-567-3224
riose3@uthscsa.edu

More Details

NCT ID
NCT03298958
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

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.