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

The University of Texas System (UT)

Status and phase

Withdrawn

Phase 3

Conditions

Bladder Cancer

Treatments

Drug: Placebo Oral Tablet

Drug: Rapamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT03298958

HSC20170277H

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)