Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Post-Solid Organ Transplant Skin Neoplasms	Drug: Difluoromethylornithine	Phase II

MedlinePlus related topics:

Cancer Skin Cancer

ChemIDplus related topics:

Eflornithine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability [ Time Frame: for 12 months ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	52
Study Start Date:	July 2003
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204789

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators


Principal Investigator:	Howard H Bailey, MD	University of Wisconsin, Madison

More Information

Study ID Numbers:	2001-414, CO00318
First Received:	September 12, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00204789
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases

Eflornithine

Skin Neoplasms

Additional relevant MeSH terms:

Anti-Infective Agents

Trypanocidal Agents

Antiparasitic Agents

Antiprotozoal Agents

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00204789