A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

March 17, 2021 updated by: The University of Texas Health Science Center at San Antonio

A Randomized Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate change from baseline in gamma-delta T cell numbers and function and Ag85 peptide-specific T cell responses following treatment.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
  • In their treating physician's opinion is a good candidate for BCG therapy
  • 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)
  • Individuals who are not a good candidate for BCG in their treating physician's opinion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rapamycin 0.5mg
Subject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days
Drug: Sirolimus
Other Names:
  • Rapamycin
  • Rapamune
Active Comparator: Rapamycin 2.0mg
Subject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days
Drug: Sirolimus
Other Names:
  • Rapamycin
  • Rapamune
No Intervention: Control
Subject will be apart of the control group and won't take the study drug being tested

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in systemic (whole blood) gamma-delta T cells frequency
Time Frame: 4 weeks and 3 months after therapy
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
4 weeks and 3 months after therapy
Percentage change in systemic (whole blood) gamma-delta T cell proliferation in response to BCG-specific antigens
Time Frame: 4 weeks and 3 months after therapy
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
4 weeks and 3 months after therapy
Percentage change in systemic (whole blood) Ag85 peptide-specific CD4 and CD8 T lymphocytes measured using human IFN-gamma release.
Time Frame: 4 weeks and 3 months after therapy
Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
4 weeks and 3 months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Robert Svatek, MD, The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

March 2, 2021

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20160162H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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