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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Subject will be randomized to one of the 2 arms
Subject will be randomized to one of the 2 arms
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)
Time frame: Patients are treated for 2 years or until disease relapse
To determine effects of rapamycin on recurrence-free survival (RFS) for subgroup of patients with non-muscle invasive bladder cancer concurrently receiving BCG immune therapy.
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)
Time frame: Patients are treated for 2 years or until disease relapse
To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG.
BCG antigen-specific IFN-gamma ELISPOT responses will be measured
Time frame: baseline and 6 months after registration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.