Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
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
- Bladder Cancer
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
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo Oral Tablet |
Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence |
|
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 |
|
More Details
- Status
- Withdrawn
- Sponsor
- The University of Texas Health Science Center at San Antonio