Precancerous Condition Clinical Trial
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
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 |
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.
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Applied Genetics |
United States, Germany, United Kingdom,
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 |