A Phase 3 interventional study of Rapamycin and Placebo Oral Tablet in Bladder Cancer, sponsored by The University of Texas Health Science Center at San Antonio. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 3, Interventional, and Treatment
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).
Exclusion Criteria:
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 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
Also known as: Sirolimus
Subject will be randomized to one of the 2 arms
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
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio