Clinical Trials Logo

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
Est. completion date
Est. primary completion date
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


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, 

See also
  Status Clinical Trial Phase
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT00550589 - Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Phase 2
Completed NCT00653146 - The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia N/A
Terminated NCT00629577 - Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples Phase 1
Completed NCT00103246 - Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides Phase 1
Completed NCT00066430 - Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Phase 1
Completed NCT00522197 - ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia Phase 2
Completed NCT00003384 - Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer N/A
Terminated NCT02574442 - Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer
Completed NCT00719563 - American Ginseng in Treating Patients With Fatigue Caused by Cancer Phase 3
Terminated NCT00899951 - Studying Fentanyl in Patients With Cancer N/A
Completed NCT00873288 - Activating Collaborative CIS Support Via Targeted Provider Mailing N/A
Terminated NCT00611650 - Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia Phase 2
Completed NCT00462813 - Diindolylmethane in Treating Patients With Abnormal Cervical Cells Phase 3
Completed NCT00006348 - Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment Phase 3
Completed NCT00666731 - Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
Recruiting NCT04445532 - Hepatobiliary Tumors Tissue Samples Acquisition
Completed NCT00685568 - Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis Phase 1
Terminated NCT00942422 - Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma Phase 2
Completed NCT00788164 - Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia Phase 1