Non-melanomatous Skin Cancer 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
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00423397 -
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
|
Phase 1/Phase 2 | |
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 | |
Active, not recruiting |
NCT00391300 -
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
|
Phase 1 | |
Completed |
NCT00066872 -
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
|
Phase 3 | |
Completed |
NCT00021294 -
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
|
Phase 2 | |
Completed |
NCT00003611 -
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
|
N/A | |
Terminated |
NCT00663910 -
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
|
Phase 0 | |
Recruiting |
NCT00295906 -
Computer-Based Continuing Education for Doctors in Examination and Counseling of Patients on Skin Cancer or Weight Control
|
N/A | |
Completed |
NCT00025012 -
Isotretinoin in Preventing Skin Cancer
|
N/A | |
Completed |
NCT00021125 -
Radiation Therapy in Treating Patients With Head and Neck Cancer
|
Phase 3 | |
Completed |
NCT00601640 -
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
|
Phase 2 | |
Completed |
NCT00079300 -
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
Completed |
NCT00017485 -
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
Recruiting |
NCT00747903 -
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
|
Phase 2 | |
Terminated |
NCT00899132 -
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
|
N/A | |
Completed |
NCT00099112 -
Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
|
N/A | |
Completed |
NCT00644384 -
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer
|
N/A | |
Completed |
NCT00023621 -
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
|
Phase 2 | |
Completed |
NCT00002975 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 | |
Completed |
NCT00295958 -
LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
|
Phase 2 |