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

Further Study Details: 

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 (morpheaform basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients within each group are randomized to receive one of three application times: 4-5, 20-22 or 48-50 hours in duration.

Aminolevulinic acid is topically applied in a cream mixture 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven basal cell carcinoma or squamous cell carcinoma
• Candidate for complete surgical excision

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No inflammation or infection of treated area

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Biopsy at least 2 weeks prior to surgery

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:  CDR0000065449; RPCI-DS-92-42; NCI-V97-1191; NCT00002963
Record last reviewed:  June 2004
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002963
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08