Basal Cell Carcinoma of the Skin, Pain, Recurrent Skin Cancer
Conditions
Brief 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
Detailed description
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.
Interventions
DRUGmethyl-5-aminolevulinate hydrochloride cream
Applied topically
DRUGphotodynamic therapy
Undergo light-emitting diode photodynamic therapy
PROCEDURElaser therapy
Undergo laser light photodynamic therapy
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irradiance-dependent pain threshold | 30-60 sec after the initial low irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the high irradiance increase, and every 3-5 min until end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of treatment in terms of clinical response | At 5-7 days, at 6-12 months, and at 24 months |
Countries
United States
Outcome results
None listed