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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03298958
• Other study ID #: HSC20170277H
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2019
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Rapamycin
Subject will be randomized to one of the 2 arms
• Placebo Oral Tablet
Subject will be randomized to one of the 2 arms

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Patients are treated for 2 years or until disease relapse
Secondary	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)	Patients are treated for 2 years or until disease relapse
Secondary	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	baseline and 6 months after registration