Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer

Inclusion Criteria

• •Previous treatment for basal or squamous cell skin cancer stage 0-2 and current evidence of at least actinic keratosis on the upper extremities (upper arms, forearms and hands), neck, face or scalp.
• •\>18 years of age
• •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
• •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 intended treatment areas 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
• •Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 365 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 urine pregnancy test 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)
• •The effects of DFMO and diclofenac on the developing fetus are unknown. Therefore, all females of childbearing potential and all men capable of fathering a child 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
• •Biopsy proven hepatic cirrhosis
• •Keloid formation
• •Photosensitivity disorder
• •Hypersensitivity or adverse reactions to nonsteroidal anti-inflammatory agents
• •Oral DFMO for \> 1 month on a prior study
• •Any disease that predisposes to NMSC
• •An immunodeficiency disorder or the use of an immunosuppressive drug
• •• Concurrent use of the following medications or treatments:
• •Systemic therapy with psoralens, immunotherapy, or retinoids.
• •Cytotoxic chemotherapy for any reason (including methotrexate for arthritis)
• •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 her study physician immediately.
• •* Uncontrolled concurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, 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.