photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream in determining pain threshold in patients with skin cancer

Conditions: Basal Cell Carcinoma of the Skin; Pain; Recurrent Skin Cancer

Summary: rationale: photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. when the drug is active, cancer cells are killed. photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer. purpose: this phase i trial is studying the side effects and best dose of photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold patients with skin cancer

primary objectives: i. to determine the "low" initial irradiance that causes no or minimal (pain grade of \< 4) during the time period during which 90 +/- 10% photo bleaching of protoporphyrin ix (pplx) in the lesion occurs, and which precedes the "high" irradiance portion of mal/pdt. ii. to determine the effects of preceding "low" irradiance on the pain level of the "high" irradiance portion of mal-pdt. secondary objectives: i. to determine the effects of irradiance on lesion perfusion. ii. to determine ppix and total vit d content in blood. tertiary objectives: i. to monitor the clinical outcomes of the treatments for initial response and recurrences. outline: patients are randomized to 1 of 2 treatment arms. group i: patients apply methyl-5-aminolevulinate hydrochloride (mal) cream on the lesions and the surrounding normal skin. beginning 3 hours later, patients undergo laser light treatment for 3-5 minutes. group ii: patients apply mal cream on the lesions and the surrounding normal skin. beginning 3 hours later, patients undergo light-emitting diode treatment for 10-20 minutes. after completion of study treatment, patients are followed up at 5-7 days, at 6-12 months, and at 24 months.

Eligibility criteria:
inclusion criteria: * patients with 1-2 superficial basal cell carcinoma (sbcc), 0.5 to 2 cm in diameter * primary or recurrent lesions may be treated * diagnosis must be confirmed by biopsy, at least 2 weeks pre treatment * each patient with \< 8 lesions can contribute a maximum of 2 lesions per treatment session, 1 lesion per light source, which can be treated the same day as permitted by scheduling; the remaining lesions may be treated as soon as scheduling permits with non protocol photodynamic therapy * patient or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * patients not meeting the above selection criteria * lesions which are not suitable for diagnostic measurements * patients with \>= 8 lesions to be treated * carcinomas of types known to have uncertain clinical margins (e.g. morpheaform or infiltrating), or any lesion felt to require mohs surgery for definitive control * lesions over boney prominences * patients with porphyrias or known hypersensitivity to porphyrins * patients with known photosensitivity diseases * patients with allergies to metvixia (mal) cream ingredients (peanut and almond oil) * patients previously treated with a systemic photo sensitizer within 4 months * pregnant or nursing female patients * patients unwilling or unable to follow protocol requirements * any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug