RATIONALE: 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.

PURPOSE: 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.

Condition	Treatment or Intervention	Phase
recurrent skin cancer basal cell carcinoma of the skin squamous cell carcinoma of the skin actinic keratosis	Drug: T4N5 liposomal lotion  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer	Phase II

Further Study Details: 

OBJECTIVES: Primary

• 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 liposomal lotion vs placebo.

Secondary

• Compare the proportion of these patients who develop NMSC on sun-exposed skin during treatment and after cesssation of treatment with these regimens.
• Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation of treatment with these regimens.
• Compare the incidence of recurrent and de novo actinic keratoses (AKs) in patients treated with these regimens.
• Determine whether either of these regimens induces regression of AKs left untreated on the sun-exposed skin of these patients.
• Compare the proportion of these patients who develop melanoma, in both treated and untreated sites, during and after cessation of treatment with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study center and time since transplantation (4-8 years post-transplantation vs > 8 years post-transplantation). Patients are randomized to 1 of 2 arms.

Six months before randomization, lesions suspicious for nonmelanoma skin cancer (NMSC) are surgically removed and histologically analyzed. All but 10 randomly selected non-suspicious lesions are removed. Of these 10 lesions, 5 are shave biopsied immediately pre-treatment for histologic and surrogate endpoint biomarker (SEB) analysis and to determine a baseline actinic keratosis:wart ratio. Patients also undergo a pre-treatment biopsy of normal appearing sun-exposed and non-sun-exposed skin (buttocks).

• Arm I: 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.
• Arm II: Patients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months. Treatment in both arms continues in the absence of the development of metastatic cutaneous squamous cell cancer or melanoma.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 6 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine clearance ≥ 20 mL/min
• Creatinine must be within 0.4 mg/dL of a value taken 6 months ago

Integumentary

• No history of keloid formation
• No known photosensitivity disorder

Other

• 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, or 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 other medical or psychosocial condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• More than 30 days since prior and no concurrent topical chemotherapy (including topical fluorouracil) to areas being studied

Endocrine therapy

• No concurrent topical preparations containing corticosteroids

Radiotherapy

• More than 30 days since prior and no concurrent local radiotherapy to a study area

Surgery

• See Disease Characteristics
• More than 30 days since prior and no concurrent cryotherapy to target lesions

Other

• 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 suncreen allowed
• No concurrent topical preparations containing vitamin A derivatives
• No concurrent nonsteroidal anti-inflammatory drugs
• Concurrent cardioprotective doses of aspirin (< 100 mg/day) allowed

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115-3010,  United States; Recruiting
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0314,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting

Study chairs or principal investigators

Craig A. Elmets, MD,  Principal Investigator,  UAB Comprehensive Cancer Center   

Study ID Numbers:  CDR0000378098; UAB-0323; NCT00089180
Record last reviewed:  August 2004
Last Updated:  February 15, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00089180
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08