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

Phase 2

Completed

• Conditions: Skin Neoplasms; Post-solid Organ Transplant

• Registration Number: NCT00204789
• Lead Sponsor: University of Wisconsin, Madison

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

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability	for 12 months

Secondary Outcome Measures

Name	Time	Method
To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%	for the 12 months of therapy
To determine if DFMO will be able to decrease polyamine levels in skin biopsies	for the 12 months of treatment