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

Overview

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

Full Title of Study: “A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance – Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

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

  • Drug: methyl-5-aminolevulinate hydrochloride cream
    • Applied topically
  • Drug: photodynamic therapy
    • Undergo light-emitting diode photodynamic therapy
  • Procedure: laser therapy
    • Undergo laser light photodynamic therapy

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Irradiance-dependent pain threshold
    • 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

Secondary Measures

  • Efficacy of treatment in terms of clinical response
    • Time Frame: At 5-7 days, at 6-12 months, and at 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Roswell Park Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ilene L Rothman, MD, Principal Investigator, Roswell Park Cancer Institute

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