Status:
COMPLETED
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Post-solid Organ Transplant
Skin Neoplasms
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 ar...
Eligibility Criteria
Inclusion
- \>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
- 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)
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00204789
Start Date
July 1 2003
End Date
December 1 2007
Last Update
December 16 2019
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