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

This study is ongoing, but not recruiting participants.

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

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Tranilast   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   July 1996

Detailed 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.

  Eligibility
Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002811

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

Sponsors and Collaborators
Applied Genetics

Investigators
Study Chair:     Daniel B. Yarosh, PhD     Applied Genetics    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064945, AGI-007, AGI-FDR000992, NCI-V96-0953
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002811
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
actinic keratosis  

Study placed in the following topic categories:
Xeroderma Pigmentosum
Keratosis
Metabolic Diseases
Precancerous Conditions
Skin Diseases
Photosensitivity Disorders
Skin Abnormalities
Tranilast
Genetic Diseases, Inborn
Congenital Abnormalities
Xeroderma pigmentosum
Metabolic disorder
Skin Diseases, Genetic
Tylosis

Additional relevant MeSH terms:
Neoplasms
Pigmentation Disorders
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on September 16, 2008




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