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

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ClinicalTrials.gov Identifier: NCT02753309
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Svatek, The University of Texas Health Science Center at San Antonio

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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



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



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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

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


Contacts
Contact: Robert S. Svatek, MD, MSCI 210-567-5676
Contact: Maggie Tomasini, MPH 210-450-0507 tomasinim@uthscsa.edu

Locations
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Maggie Tomasini, MPH    210-450-0507    tomasinim@uthscsa.edu   
Principal Investigator: Robert Svatek, MD         
Sponsors and Collaborators
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

Responsible Party: Robert Svatek, Associate Professor, Department of Urology, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02753309     History of Changes
Other Study ID Numbers: HSC20160162H
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

Keywords provided by Robert Svatek, The University of Texas Health Science Center at San Antonio:
BCG
Rapamycin

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Sirolimus
Everolimus
Urinary Bladder Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs