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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 21, 2007

Start Date ^ICMJE

July 2003

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To determine if DFMO at 500 mg daily will be well tolerated for 12 months and not effect organ transplant viability;

Change History

Complete list of historical versions of study NCT00204789 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Post-Solid Organ Transplant
Skin Neoplasms

Intervention ^ICMJE

Drug: Difluoromethylornithine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00204789

Responsible Party

Study ID Numbers ^ICMJE

2001-414, CO00318

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Howard H Bailey, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP