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