Spots Global Cancer Trial Database for Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
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Trial Identification
Brief Title: Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
Official Title: Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
Study ID: NCT00204789
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Howard H Bailey, MD
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR
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