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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Post-solid Organ Transplant Skin Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Difluoromethylornithine

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard H Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Countries

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United States

Other Identifiers

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CO00318

Identifier Type: -

Identifier Source: secondary_id

2001-414