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

Pain Clinical Trial

Official title:

A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292668
• Other study ID #: I 175410
• Secondary ID: NCI-2010-02319
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2011
• Last updated: September 26, 2014
• Start date: March 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma of the Skin
• Carcinoma, Basal Cell
• Pain
• Recurrent Skin Cancer
• Skin Neoplasms

Intervention

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

Procedure:
• laser therapy
Undergo laser light photodynamic therapy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irradiance-dependent pain threshold		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	No
Secondary	Efficacy of treatment in terms of clinical response		At 5-7 days, at 6-12 months, and at 24 months	No