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

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

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

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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer

Drug Information available for: Eflornithine

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	2001-414, CO00318
Study First Received:	September 12, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00204789 History of Changes
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
Antiprotozoal Agents
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

Skin Neoplasms
Pharmacologic Actions
Neoplasms
Antiparasitic Agents
Neoplasms by Site
Eflornithine
Therapeutic Uses

ClinicalTrials.gov processed this record on July 06, 2009