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Completed

NCT Number: NCT00204789

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

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.

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Key information

Conditions

Post-solid Organ Transplant Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Difluoromethylornithine

Drug

Primary outcomes

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

    Time frame: for 12 months

Secondary outcomes

  1. To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%

    Time frame: for the 12 months of therapy

  2. To determine if DFMO will be able to decrease polyamine levels in skin biopsies

    Time frame: for the 12 months of treatment

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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