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Secondary Prevention Trial of Rapamycin in Patients With Resected 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: NCT03298958
Recruitment Status : Withdrawn (No funding was received, no subjects were enrolled)
First Posted : October 2, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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

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Study Type : Interventional  (Clinical Trial)
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
  • 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 : November 1, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: Sirolimus




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

  2. To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG. [ Time Frame: baseline and 6 months after registration ]
    BCG antigen-specific IFN-gamma ELISPOT responses will be measured



Information from the National Library of Medicine

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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 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)

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): NCT03298958


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
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03298958    
Other Study ID Numbers: HSC20170277H
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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