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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753309
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Sirolimus Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
Study Start Date : June 2016
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : March 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753309


Locations
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United States, Texas
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
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Principal Investigator: Robert Svatek, MD The University of Texas Health Science Center at San Antonio
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02753309    
Other Study ID Numbers: HSC20160162H
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Keywords provided by The University of Texas Health Science Center at San Antonio:
BCG
Rapamycin
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Sirolimus
 Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs