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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant. Chemoprevention therapy is the use of certain drugs to try to prevent the development of or recurrence of cancer. T4N5 liposomal lotion may be effective preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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