A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
18 Years
N/A
Both
Basal Cell Carcinoma of the Skin, Pain, Recurrent Skin Cancer
Trial Information
A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Irradiance-dependent pain threshold
Outcome Time Frame:
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
Safety Issue:
No
Principal Investigator
Nathalie Zeitouni
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
I 175410
NCT ID:
NCT01292668
Start Date:
March 2011
Completion Date:
Related Keywords:
- Basal Cell Carcinoma of the Skin
- Pain
- Recurrent Skin Cancer
- Carcinoma
- Skin Neoplasms
- Carcinoma, Basal Cell
- Carcinoma, Basosquamous
- Carcinoma, Squamous Cell
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
