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| ID | Type | Description | Link |
|---|---|---|---|
| AGI-007 | |||
| AGI-FDR000992 | |||
| NCI-V96-0953 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal T4N5 lotion | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B. Yarosh, PhD | Applied Genetics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quality Research Group | Miami Beach | Florida | 33140 | United States | ||
| University of Michigan Comprehensive Cancer Center |
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| Ann Arbor |
| Michigan |
| 48109-0752 |
| United States |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-9832 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Office of Gerald Bernstein | Seattle | Washington | 98107 | United States |
| Medizinische Klinik | Munich (Muenchen) | D-80336 | Germany |
| Guy's, King's and St. Thomas' Hospitals Trust | London | England | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D043224 | Deoxyribonuclease (Pyrimidine Dimer) |
| ID | Term |
|---|---|
| D004706 | Endodeoxyribonucleases |
| D003851 | Deoxyribonucleases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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