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

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ClinicalTrials.gov Identifier: NCT01292668
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : September 29, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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

Condition or disease Intervention/treatment 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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy of treatment in terms of clinical response [ Time Frame: At 5-7 days, at 6-12 months, and at 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292668


Locations
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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
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Principal Investigator: Ilene L Rothman, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01292668    
Other Study ID Numbers: I 175410
NCI-2010-02319 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
 Neoplasms by Site
Skin Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents