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Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients

Primary Purpose

Post-solid Organ Transplant, Skin Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Difluoromethylornithine
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-solid Organ Transplant

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney Adequate organ function Hearing age/gender appropriate At high risk for developing skin cancer Immunosuppressant levels and doses show stable graft function Exclusion Criteria: Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA) Systemic therapy for cancer treatment or prophylaxis Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs [NSAIDs] (other than cardioprotective doses of aspirin)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability

    Secondary Outcome Measures

    To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%
    To determine if DFMO will be able to decrease polyamine levels in skin biopsies

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    December 12, 2019
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00204789
    Brief Title
    Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
    Official Title
    Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-solid Organ Transplant, Skin Neoplasms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Difluoromethylornithine
    Primary Outcome Measure Information:
    Title
    To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
    Time Frame
    for 12 months
    Secondary Outcome Measure Information:
    Title
    To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%
    Time Frame
    for the 12 months of therapy
    Title
    To determine if DFMO will be able to decrease polyamine levels in skin biopsies
    Time Frame
    for the 12 months of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney Adequate organ function Hearing age/gender appropriate At high risk for developing skin cancer Immunosuppressant levels and doses show stable graft function Exclusion Criteria: Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA) Systemic therapy for cancer treatment or prophylaxis Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs [NSAIDs] (other than cardioprotective doses of aspirin)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Howard H Bailey, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients

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