Photodynamic Therapy in Treating Patients With Skin Cancer
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|ClinicalTrials.gov Identifier: NCT00002963|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 31, 2013
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer.
PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.
|Condition or disease||Intervention/treatment||Phase|
|Non-melanomatous Skin Cancer||Drug: aminolevulinic acid hydrochloride Procedure: conventional surgery||Phase 2|
- Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas.
- Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients.
- Compare the results of tissue fluorescence with surface fluorescence measurements in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients within each group are randomized to receive one of two application times: 4-5 or 20-24 hours in duration.
Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an occlusive dressing placed over the lesion. After the randomized treatment duration has expired, the dressing is removed and quantitative protoporphyrin IX fluorescence measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine surgical excision is then performed on the carcinoma.
Patients return after one to two weeks for a follow-up examination and suture removal.
PROJECTED ACCRUAL: 54 patients will be accrued within 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy|
|Study Start Date :||November 1993|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
- Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002963
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Allan R. Oseroff, MD, PhD||Roswell Park Cancer Institute|