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BRIEF TITLE: Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer

Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer


  • Org Study ID: HSC20170277H
  • Secondary ID:
  • NCT ID: NCT03298958
  • NCT Alias:
  • Sponsor: The University of Texas Health Science Center at San Antonio - Other
  • Source: The University of Texas Health Science Center at San Antonio

Brief Summary

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).

Overal Status Start Date Phase Study Type
Recruiting November 1, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer

Primary Outcome 1 - Time Frame: Patients are treated for 2 years or until disease relapse

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location

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