Status:
COMPLETED
T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Actinic Keratosis
Basal Cell Carcinoma of the Skin
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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. Chemoprevent...
Detailed Description
PRIMARY OBJECTIVES: I. Compare the incidence of nonmelanoma skin cancer (NMSC) (average per patient) on the sun-exposed skin of renal transplant recipients with a history of NMSC treated with T4N5 li...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00089180
Start Date
March 1 2004
Last Update
December 4 2015
Active Locations (1)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294