Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
Status:
Withdrawn
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio