T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant
Actinic Keratosis, Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer
About this trial
This is an interventional prevention trial for Actinic Keratosis
Eligibility Criteria
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
Sites / Locations
- UAB Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (liposomal T4N5 lotion)
Arm II (placebo)
Patients apply T4N5 liposomal lotion topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.
Patients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.