Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer

NCT ID: NCT01292668

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 Type: EXPERIMENTAL

methyl-5-aminolevulinate hydrochloride cream

Intervention Type: DRUG

Applied topically

laser therapy

Intervention Type: PROCEDURE

Undergo laser light photodynamic therapy

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 5-10 minutes.

Group Type: EXPERIMENTAL

methyl-5-aminolevulinate hydrochloride cream

Intervention Type: DRUG

Applied topically

photodynamic therapy

Intervention Type: DRUG

Undergo light-emitting diode photodynamic therapy

Interventions

methyl-5-aminolevulinate hydrochloride cream

Applied topically

Intervention Type: DRUG

photodynamic therapy

Undergo light-emitting diode photodynamic therapy

Intervention Type: DRUG

laser therapy

Undergo laser light photodynamic therapy

Intervention Type: PROCEDURE

Other Intervention Names

Metvix cream; Metvixia cream; Light Infusion Therapy™; PDT; therapy, photodynamic; therapy, laser

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilene L Rothman, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2010-02319

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 175410

Identifier Type: -

Identifier Source: org_study_id