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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00204789
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 52
• Duration (Months): 53

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-solid Organ Transplant; Skin Neoplasms	Drug: Difluoromethylornithine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50% [for the 12 months of therapy]

2. To determine if DFMO will be able to decrease polyamine levels in skin biopsies [for the 12 months of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00204789
• Other Study ID Numbers: 2001-414; CO00318
• First Posted: Sep 20, 2005
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Skin Neoplasms; Eflornithine

Study Results

No Results Posted as of Dec 16, 2019