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

Primary Purpose

Bladder Cancer

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rapamycin
Placebo Oral Tablet
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Oral Tablet

Sirolimus (Rapamycin) 0.5 mg/day for 2 years

Arm Description

Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence

Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence

Outcomes

Primary Outcome Measures

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)

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.
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.
BCG antigen-specific IFN-gamma ELISPOT responses will be measured

Full Information

First Posted
September 26, 2017
Last Updated
June 7, 2019
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT03298958
Brief Title
Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
Official Title
Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No funding was received, no subjects were enrolled
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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 Placebo
Masking
ParticipantInvestigator
Masking Description
Double-blinded for study staff (investigator) and patient
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence
Arm Title
Sirolimus (Rapamycin) 0.5 mg/day for 2 years
Arm Type
Active Comparator
Arm Description
Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence
Intervention Type
Drug
Intervention Name(s)
Rapamycin
Other Intervention Name(s)
Sirolimus
Intervention Description
Subject will be randomized to one of the 2 arms
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Subject will be randomized to one of the 2 arms
Primary Outcome Measure Information:
Title
Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG.
Description
BCG antigen-specific IFN-gamma ELISPOT responses will be measured
Time Frame
baseline and 6 months after registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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