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

Phase 2CompletedNCT00204789

University of Wisconsin, Madison52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Post-solid Organ Transplant Skin Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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