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	Treatment or Intervention	Phase
actinic keratosis prevention of skin cancer	Drug: placebo  Drug: T4N5 liposomal lotion	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  2 Years   -   60 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• See Disease Characteristics

--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

Florida
      Quality Research Group, Miami Beach,  Florida,  33140,  United States
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States
Minnesota
      University of Minnesota Medical School, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New York
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-9832,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
Washington
      Office of Gerald Bernstein, Seattle,  Washington,  98107,  United States
Germany
      Medizinische Klinik, Munich (Muenchen),  D-80336,  Germany
United Kingdom, England
      Guy's, King's and St. Thomas' Hospitals Trust, London,  England,  SE1 7EH,  United Kingdom

Study chairs or principal investigators

Daniel B. Yarosh,  Study Chair,  Applied Genetics   

Study ID Numbers:  CDR0000064945; AGI-007; NCI-V96-0953; AGI-FDR000992
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002811
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08