NCT00204789

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2003

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2007

Enrollment Period

4.4 years

First QC Date

September 12, 2005

Last Update Submit

December 12, 2019

Conditions

Post-solid Organ TransplantSkin Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability

    for 12 months

Secondary Outcomes (2)

  • 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

Interventions

DifluoromethylornithineDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Eflornithine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

OrnithineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Diamino

Study Officials

  • Howard H Bailey, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 16, 2019

Record last verified: 2007-12