RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

Condition	Treatment or Intervention	Phase
basal cell carcinoma of the skin squamous cell carcinoma of the skin actinic keratosis	Drug: aminolevulinic acid  Procedure: laser therapy  Procedure: photodynamic therapy  Procedure: phototherapy	Phase II

Further Study Details: 

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 up to 2 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.

Genders Eligible for Study:  Both

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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting

Study chairs or principal investigators

Allan Oseroff, MD, PhD,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000065494; RPCI-DS-96-55; NCI-G97-1224; NCT00002975
Record last reviewed:  November 2004
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002975
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08