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

University of Wisconsin (UW)

Status and phase

Completed

Phase 2

Conditions

Post-solid Organ Transplant

Skin Neoplasms

Treatments

Drug: Difluoromethylornithine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00204789

2001-414

CO00318

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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)