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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03298958

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: Rapamycin Drug: Placebo Oral Tablet	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

When it is determined that you are eligible for the study, you will be assigned by chance (like flipping a coin) to one of 2 study groups. Sirolimus 0.5 mg/day for 2 years or until disease recurrence PlaceboWhen it is determined that you are eligible for the study, you will be assigned by chance (like flipping a coin) to one of 2 study groups. Sirolimus 0.5 mg/day for 2 years or until disease recurrence Placebo

Masking:

Double (Participant, Investigator)

Masking Description:

Double-blinded for study staff (investigator) and patient

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Oral Tablet 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 one of the 2 arms
Active Comparator: Sirolimus (Rapamycin) 0.5 mg/day for 2 years 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 Other Names: Sirolimus

Arm

Intervention/Treatment

Placebo Comparator: Placebo Oral Tablet

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 one of the 2 arms

Active Comparator: Sirolimus (Rapamycin) 0.5 mg/day for 2 years

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

Other Names:

Sirolimus

Outcome Measures

Primary Outcome Measures

Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer [Patients are treated for 2 years or until disease relapse]
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)

Secondary Outcome Measures

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. [Patients are treated for 2 years or until disease relapse]
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)
To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG. [baseline and 6 months after registration]
BCG antigen-specific IFN-gamma ELISPOT responses will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT03298958

Other Study ID Numbers:

HSC20170277H

First Posted:

Oct 2, 2017

Last Update Posted:

Jun 12, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Sirolimus

Study Results

No Results Posted as of Jun 12, 2019