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

NCT ID: NCT00089180

Last Updated: 2015-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

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. 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.

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 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.

Conditions

Actinic Keratosis; Basal Cell Carcinoma of the Skin; Recurrent Skin Cancer; Squamous Cell Carcinoma of the Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I (liposomal T4N5 lotion)

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.

Group Type: EXPERIMENTAL

liposomal T4N5 lotion

Intervention Type: DRUG

Given topically

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Arm II (placebo)

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given topically

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

liposomal T4N5 lotion

Given topically

Intervention Type: DRUG

placebo

Given topically

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

bacteriophage T4 endonuclease V in liposomal lotion; Dimericine; T4 endonuclease V liposomal lotion; T4N5 liposomal lotion; PLCB

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Elmets

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-0323

Identifier Type: -

Identifier Source: secondary_id

CDR0000378098

Identifier Type: -

Identifier Source: secondary_id

N01CN15136

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-2012-02619

Identifier Type: -

Identifier Source: org_study_id