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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 24, 2014