Clinical trial NCT01292668: Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer
Official title: A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Basal Cell Carcinoma of the Skin
Pain
Recurrent Skin Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Irradiance-dependent pain threshold
timeFrame: 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 outcomes:
measure: Efficacy of treatment in terms of clinical response
timeFrame: At 5-7 days, at 6-12 months, and at 24 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Ilene L Rothman, MD
role: PRINCIPAL_INVESTIGATOR
References: