Topical Chemoprevention of Skin Cancer Biomarkers

Inclusion Criteria

• •o Ability to understand and willingness to sign a written informed consent document
• •ECOG performance status 0-1
• •Willing and able to participate for the full duration of the study
• •Greater than 4 weeks from:
• •Prior major surgery for any indication Prior chemotherapy, hormonal therapy or radiation therapy for cancer o Willing to abstain from: The application of topical medications including prescription and over the counter preparations (e.g. Topical preparations containing corticosteroids or vitamin A derivatives) to areas of actinic damage for the duration of the study. Use of moisturizers/emollients and sunscreens on these areas is allowed.
• •Chronic (defined as \> 3 times/week for more than 2 consecutive weeks/year) NSAID and COX-2 inhibitor use (other than cardioprotective doses of aspirin \< 100 mg po QD) for the duration of the study. For routine analgesia, subjects may take acetaminophen as necessary.
• •Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 14 days of registration) Hematologic • WBC \> 3,000/ul • Hemoglobin \> lower limit of normal • Platelet count \> 100,000/ul Hepatic
• •• Total bilirubin \< 1.5 X ULN
• •• AST (SGOT) \< 1.5 X ULN
• •* ALT (SPGT) \< 1.5 X ULN Renal
• •* Serum creatinine \< 1.5 X ULN
• •* BUN \< 1.5 X ULN
• •Females of childbearing potential must:
• •Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses Have a documented negative serum pregnancy test within 14 days prior to the first dose of study medication Females are not considered to be of childbearing potential if they are at least 1 year post-menopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.
• •o The effects of topical DFMO + topical diclofenac on the developing fetus are unknown. Therefore all females of childbearing potential must agree to use adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) for the duration of study participation.
• •Solid organ or bone marrow transplant Keloid formation Photosensitivity disorder Hypersensitivity or adverse reactions to nonsteroidal anti-inflammatory agents or to DFMO Any disease that predisposes to NMSC An immunodeficiency disorder or the use of an immunosuppressive drug Any skin disease that would interfere with interpretation of results
• •Any family history of Ornithine diaminotransferase deficiency in a first degree relative
• •Concurrent use of the following medications or treatments Anticoagulants including warfarin and heparin Other NSAIDs (other than aspirin \<100 mg/day) on a daily basis Topical chemotherapy, cryotherapy, radiotherapy or any other skin lesion treatment to areas of skin being followed in this study Systemic therapy with psoralens, immunotherapy, retinoids, or radiation therapy Cytotoxic chemotherapy for any reason (including methotrexate for arthritis) Laser resurfacing, dermabrasion or chemical peels Topical or systemic immunosuppressive therapy.
• •Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately.
• •Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.