Post-solid Organ Transplant, Skin Neoplasms
Conditions
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.
Interventions
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability | for 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed