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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01292668
First received: February 8, 2011
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Basal Cell Carcinoma of the Skin
Pain
Recurrent Skin Cancer
 Drug: methyl-5-aminolevulinate hydrochloride cream
Drug: photodynamic therapy
Procedure: laser therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: March 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: methyl-5-aminolevulinate hydrochloride cream
Applied topically
Other Names:
  • Metvix cream
  • Metvixia cream
Procedure: laser therapy
Undergo laser light photodynamic therapy
Other Name: therapy, laser
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.
 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292668

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nathalie Zeitouni Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01292668     History of Changes
Other Study ID Numbers: I 175410, NCI-2010-02319
Study First Received: February 8, 2011
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
 Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013