Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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.