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| Sponsored by: |
Applied Genetics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002811 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Precancerous/Nonmalignant Condition |
Drug: T4N5 liposomal lotion |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 1996 |
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.
Eligibility| Ages Eligible for Study: | 2 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| Quality Research Group | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, Minnesota | |
| University of Minnesota Medical School | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| State University of New York Health Sciences Center - Stony Brook | |
| Stony Brook, New York, United States, 11790-9832 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Office of Gerald Bernstein | |
| Seattle, Washington, United States, 98107 | |
| Germany | |
| Medizinische Klinik | |
| Munich (Muenchen), Germany, D-80336 | |
| United Kingdom, England | |
| Guy's, King's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 7EH | |
| Study Chair: | Daniel B. Yarosh, PhD | Applied Genetics |
More Information
| Study ID Numbers: | CDR0000064945, AGI-007, AGI-FDR000992, NCI-V96-0953 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002811 History of Changes |
| Health Authority: | United States: Federal Government |
|
actinic keratosis |
|
Xeroderma Pigmentosum Keratosis Metabolic Diseases Precancerous Conditions Skin Diseases Photosensitivity Disorders Pigmentation Disorders |
Skin Abnormalities Tranilast Genetic Diseases, Inborn Congenital Abnormalities Skin Diseases, Genetic Metabolic Disorder Tylosis |
|
Xeroderma Pigmentosum Keratosis Metabolic Diseases Precancerous Conditions Skin Diseases Photosensitivity Disorders Pigmentation Disorders |
DNA Repair-Deficiency Disorders Skin Abnormalities Neoplasms Genetic Diseases, Inborn Congenital Abnormalities Skin Diseases, Genetic |
