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

Completed · Phase 2 · Has a placebo group

Conditions studied: Actinic Keratosis, Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin

In brief

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.

Key facts

Study ID

NCT00089180

Run by

National Cancer Institute (NCI)

People needed

100

Starts

2004-03-01

Last updated by the study team

2015-12-04

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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