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
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
| Completed |
NCT00653146 -
The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
|
N/A | |
| Completed |
NCT00550589 -
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
|
Phase 2 | |
| 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 |