A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses
N/A
N/A
Both
Non-melanomatous Skin Cancer, Precancerous Condition
Trial Information
A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses
OBJECTIVES:
- Determine the efficacy of aminolevulinic acid and laser irradiation in patients with
superficial and nodular epidermally derived lesions.
OUTLINE: This is a randomized study. Patients are stratified according to lesion type
(superficial basal cell carcinoma [BCC] vs nodular BCC vs superficial squamous cell
carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are
randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).
ALA is topically applied in a cream mixture and an occlusive dressing is placed over the
lesion. After the randomized duration of ALA application has expired, the dressing is
removed and a dye laser is used to treat the lesion.
Patients are followed for 2-5 years after treatment.
PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50
lesions are required for each stratified group.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Actinic keratoses
- Histologically proven superficial or nodular basal cell carcinoma (BCC),
squamous cell carcinoma in situ (Bowen's disease), or microinvasive squamous
cell carcinoma
- No nodular BCC greater than 4 mm thick that will not be surgically removed
- No carcinoma with uncertain margins requiring Moh's surgery
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No known photosensitivity disease
- No porphyria or hypersensitivity to porphyrins
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior treatment with systemic photosensitizer that would cause residual cutaneous
photosensitivity during study participation
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Safety Issue:
No
Principal Investigator
Nathalie Zeitouni, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000065494
NCT ID:
NCT00002975
Start Date:
February 1997
Completion Date:
April 2010
Related Keywords:
- Non-melanomatous Skin Cancer
- Precancerous Condition
- basal cell carcinoma of the skin
- squamous cell carcinoma of the skin
- actinic keratosis
- Skin Neoplasms
- Keratosis
- Keratosis, Actinic
- Precancerous Conditions
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
