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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204789
First received: September 12, 2005
Last updated: December 21, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Post-Solid Organ Transplant
Skin Neoplasms
Drug: Difluoromethylornithine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 Measures:
  • To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50% [ Time Frame: for the 12 months of therapy ]
  • To determine if DFMO will be able to decrease polyamine levels in skin biopsies [ Time Frame: for the 12 months of treatment ]

Estimated Enrollment: 52
Study Start Date: July 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204789

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Howard H Bailey, MD University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204789     History of Changes
Other Study ID Numbers: 2001-414, CO00318
Study First Received: September 12, 2005
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Eflornithine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 15, 2014