T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant

Inclusion Criteria

• •History of histologically confirmed nonmelanoma skin cancer
• •Renal transplant recipient ≥ 4 years ago
• •* Currently receiving standard multi-agent pharmacologic immunosuppression
• •Fitzpatrick skin type I, II, or III
• •Sun-damaged skin with ≥ 10 lesions consistent with actinic keratoses OR wart on the upper extremities (arms, forearms, hands), neck, face, and exposed scalp combined
• •No history of keloid formation
• •No known photosensitivity disorder
• •No history of malignant melanoma
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No diagnosis of acute allograft rejection within the past 30 days requiring an increase in immunosuppression
• •No invasive malignancy within the past 4 years except curatively excised NMSC, cured polyclonal posttransplantation lymphoproliferative disease, carcinoma in situ of the cervix, stage 0 chronic lymphocytic leukemia, unless all of the following criteria are met:
• •* No current evidence of disease
• •* No treatment for the invasive malignancy within the past 6 months
• •* No concurrent or planned therapy for the invasive malignancy
• •* Has an expected disease-free survival of at least 5 years
• •No diagnosis of melanoma or melanoma in situ
• •No other medical or psychosocial condition that would preclude study participation
• •No likelihood, in the opinion of the transplant surgeon/nephrologist, to experience graft loss and/or discontinue standard immunosuppressive therapy during study treatment
• •More than 30 days since prior and no concurrent topical chemotherapy (including topical fluorouracil) to areas being studied
• •No concurrent topical preparations containing corticosteroids
• •More than 30 days since prior and no concurrent local radiotherapy to a study area
• •More than 30 days since prior and no concurrent cryotherapy to target lesions
• •No prior or concurrent experimental immunosuppressive agents
• •More than 30 days since prior investigational medication
• •More than 30 days since prior and no concurrent systemic psoralens or retinoids
• •More than 60 days since prior and no concurrent laser resurfacing, dermabrasion, or chemical peels to a study area
• •No other concurrent investigational agents
• •No other concurrent topical medications, including prescription and over the counter preparations, to the areas being studied (e.g., upper arms, forearms, neck, face, and scalp)
• •* Concurrent moisturizer, emollient, and sunscreen allowed
• •No concurrent topical preparations containing vitamin A derivatives
• •No concurrent nonsteroidal anti-inflammatory drugs
• •* Concurrent cardioprotective doses of aspirin (\< 100 mg/day) allowed