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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)
• Treatments: Eflornithine

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)