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

Precancerous Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002811
• Other study ID #: CDR0000064945
• Secondary ID: AGI-007AGI-FDR00
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: November 5, 2013
• Start date: July 1996

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 60 Years

Eligibility

DISEASE CHARACTERISTICS: Diagnosis of xeroderma pigmentosum confirmed by unscheduled DNA synthesis assay At least one histologically confirmed actinic keratosis All actinic keratoses removed prior to treatment No associated syndromes, e.g., Cockayne's syndrome or trichothiodystrophy

PATIENT CHARACTERISTICS: Age: 1.66 to 60 Other: Good general health and mental capacity No illegal drug use No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Precancerous Condition
• Precancerous Conditions
• Xeroderma Pigmentosum

Intervention

Drug:
• liposomal T4N5 lotion

Locations

Country	Name	City	State
Germany	Medizinische Klinik	Munich (Muenchen)
United Kingdom	Guy's, King's and St. Thomas' Hospitals Trust	London	England
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Quality Research Group	Miami Beach	Florida
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Office of Gerald Bernstein	Seattle	Washington
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Applied Genetics

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom,