A Phase IIb Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Topical Bacteriophage T4 Endonuclease V in Renal Allograft Recipients With a History of Non-melanoma Skin Cancer
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
liposomal lotion vs placebo.
I. Compare the proportion of these patients who develop NMSC on sun-exposed skin during
treatment and after cessation of treatment with these regimens.
II. Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation
of treatment with these regimens.
III. Compare the incidence of recurrent and de novo actinic keratoses (AKs) in patients
treated with these regimens.
IV. Determine whether either of these regimens induces regression of AKs left untreated on
the sun-exposed skin of these patients.
V. 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. 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Incidence of nonmelanoma skin cancer (NMSC)
Descriptive statistics such as mean, median, standard deviation will be calculated to summarize the number of new NMSC for each of the two randomization arms and compared using the Wilcoxon rank-sum test.
Up to 18 months
University of Alabama at Birmingham
United States: Institutional Review Board
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|