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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01292668
First received: February 8, 2011
Last updated: January 3, 2014
Last verified: January 2014

February 8, 2011
January 3, 2014
March 2011
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01292668 on ClinicalTrials.gov Archive Site
Efficacy of treatment in terms of clinical response [ Time Frame: At 5-7 days, at 6-12 months, and at 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer
A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Basal Cell Carcinoma of the Skin
  • Pain
  • Recurrent Skin Cancer
  • Drug: methyl-5-aminolevulinate hydrochloride cream
    Applied topically
    Other Names:
    • Metvix cream
    • Metvixia cream
  • Drug: photodynamic therapy
    Undergo light-emitting diode photodynamic therapy
    Other Names:
    • Light Infusion Therapy™
    • PDT
    • therapy, photodynamic
  • Procedure: laser therapy
    Undergo laser light photodynamic therapy
    Other Name: therapy, laser
  • 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.
    Interventions:
    • Drug: methyl-5-aminolevulinate hydrochloride cream
    • Procedure: laser therapy
  • 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.
    Interventions:
    • Drug: methyl-5-aminolevulinate hydrochloride cream
    • Drug: photodynamic therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
Not Provided
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01292668
I 175410, NCI-2010-02319
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Ilene L Rothman, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP