A Phase IIb Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Topical Bacteriophage T4 Endonuclease V in Renal Allograft Recipients With a History of Non-melanoma Skin Cancer

Date de début de l'étude : 1 mars 2004

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