Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Keratosis, Actinic

Keratosis

Precancerous Conditions

Xeroderma Pigmentosum

Ichthyosis

Skin Diseases

Congenital Abnormalities

Skin Abnormalities

Infant, Newborn, Diseases

Skin Diseases, Genetic

Genetic Diseases, Inborn

Photosensitivity Disorders

Pigmentation Disorders

DNA Repair-Deficiency Disorders

Metabolic Diseases

liposomal T4N5 lotion

Daniel B. Yarosh, PhD

RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum.

PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin damage in patients with xeroderma pigmentosum.

OBJECTIVES: I. Compare the safety and efficacy of T4N5 liposome lotion vs. a placebo lotion in reducing the incidence of actinic keratoses and protecting against other ultraviolet skin damage in patients with xeroderma pigmentosum.

OUTLINE: Randomized, double-blind study. Groups of 6 patients are randomly assigned in a 2:1 ratio to Arms I and II, respectively. Arm I: Chemoprevention. Lotion composed of T4 endonuclease V protein encapsulated in liposomes and suspended in phosphate-buffered saline in a hydrogel base, T4N5 Liposome Lotion, T4N5. Arm II: Control. Liposomes suspended in phosphate-buffered saline in a hydrogel base, Placebo, PLCB.

PROJECTED ACCRUAL: 6-30 patients will be entered in this multicenter study.

T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum

A RANDOMIZED, DOUBLE BLIND, MULTI-CENTER CLINICAL STUDY TO TEST THE SAFETY AND EFFICACY OF T4N5 LIPOSOME LOTION ON PATIENTS WITH XERODERMA PIGMENTOSUM IN THE PROTECTION AGAINST ACTINIC KERATOSES

Applied Genetics

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

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.

Patients apply placebo topically to non-occluded, sun-exposed areas of the head, neck, face, and upper extremities once daily for 12 months.

placebo

laboratory biomarker analysis

Craig Elmets

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.

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 liposomal lotion vs placebo.

SECONDARY OBJECTIVES:

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.

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

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

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.

Calculated for the study drug and placebo arms and compared using the Fisher's exact or chi-square test.

Summarized by treatment arm and compared using the Wilcoxon rank-sum test.

Summarized by treatment arm and compared using the Wilcoxon rank-sum test. Similarly, multivariate Poisson regression model will be utilized to compare the cumulative number of incident AKs at the end of treatment as a function of treatment arm and covariates.

Summarized by treatment group and compared using the Wilcoxon rank-sum test. Similarly, multivariate Poisson regression model will be utilized to compare the cumulative number of regressed AKs at the end of treatment as a function of treatment group and covariates. In addition to the covariates listed above, the number of AKs at baseline will be included as a covariate in the model.

The data will be collected and analyzed by scoring both total body melanoma distribution and those in lotion treatment sites. Relative risk will be calculated for the development of melanomas. The Chi-Square test will be used to explore the risk relationships.

Descriptive statistics will be calculated at baseline and end of treatment for several SEBs by treatment arm. The change in SEB levels will be also calculated for each patient and compared between treatment arms using either the two-sample t-test or Wilcoxon rank-sum test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum	NCT00002811	Precancerous Co...	liposomal T4N5 ...	2 Years - 60 Years	National Cancer Institute (NCI)
T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant	NCT00089180	Actinic Keratos... Basal Cell Carc... Recurrent Skin ... Squamous Cell C...	liposomal T4N5 ... placebo laboratory biom...	19 Years -	National Cancer Institute (NCI)

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