RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if photodynamic therapy is more effective with or without methyl-5-aminolevulinate in treating patients with skin cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of photodynamic therapy with or without methyl-5-aminolevulinate in treating patients who have basal cell carcinoma.

Condition	Treatment or Intervention	Phase
basal cell carcinoma of the skin	Procedure: surgery  Procedure: laser therapy  Procedure: phototherapy  Procedure: photodynamic therapy  Procedure: conventional surgery  Drug: methyl-5-aminolevulinate	Phase III

Further Study Details: 

OBJECTIVES: I. Determine the complete response rate in patients with primary nodular basal cell carcinoma of the skin treated with photodynamic therapy using methyl-5-aminolevulinate. II. Determine the number of lesions, lesion response rates, clinical complete response, cosmetic outcome, and adverse events in patients treated with this regimen.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Methyl-5-aminolevulinate is topically applied in a cream mixture to all lesions. Arm II: Placebo cream is topically applied to all lesions. Patients in both arms have an occlusive dressing placed over the treated lesions for 3 hours. All patients undergo photodynamic light therapy for 5-10 minutes after the dressing is removed. Treatment repeats in 1 week for a total of 2 treatments. After 3 months, patients with either no response or progression undergo surgical excision, and patients with a partial response receive an additional course of photodynamic therapy. At 6 months after the first or second (if given) treatment course, all lesions not previously removed are excised regardless of response. Patients are followed at 2 and 4 weeks and then at 3, 6, and 9 months.

PROJECTED ACCRUAL: A total of 62 patients (31 per treatment arm) will be accrued for this study within 3 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed primary nodular basal cell carcinoma (BCC) of the skin
• Eligible for simple excision surgery
• No lesions in previously irradiated area
• No lesions in periorbital area, ears, or nasolabial fold
• No lesion less than 6 mm or greater than 15 mm in diameter on face/scalp, greater than 20 mm on extremities or neck, or greater than 30 mm on trunk
• No pigmented nodular lesions
• No morpheaform nodular lesions
• No infiltrating nodular lesions
• No porphyria, Gorlin's syndrome, or xeroderma pigmentosum

--Prior/Concurrent Therapy--

• No prior therapy for BCC
• Biologic therapy: Not specified
• Chemotherapy: No prior arsenic exposure
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics
• Surgery: See Disease Characteristics
• Other: At least 30 days since prior enrollment on another clinical study; No concurrent enrollment on another clinical study; No concurrent immunosuppressive medication

--Patient Characteristics--

• Age: Over 18
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 month after study; No known allergy to methyl-5-aminolevulinate, a similar photodynamic therapy compound, or any components of the cream

California
      Office of Nicholas Lowe, Santa Monica,  California,  90404-2115,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
Virginia
      Virginia Clinical Research, Inc., Norfolk,  Virginia,  23507,  United States

Study chairs or principal investigators

Allan Oseroff,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000068823; RPCI-DS-0025; NCI-G01-2003; PC-T307/00
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022503
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08