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

NCT01292668 | Completed Phase 1 DMC

• 2 other identifiers: I 175410NCI-2010-02319
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Basal Cell Carcinoma of the Skin; Pain; Recurrent Skin Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Efficacy of treatment in terms of clinical response

  At 5-7 days, at 6-12 months, and at 24 months

Study Arms (2)

Group I

EXPERIMENTAL

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; Procedure: laser therapy

Group II

EXPERIMENTAL

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; Drug: photodynamic therapy

Interventions

methyl-5-aminolevulinate hydrochloride cream DRUG

Applied topically

Also known as: Metvix cream, Metvixia cream

Group I; Group II

photodynamic therapy DRUG

Undergo light-emitting diode photodynamic therapy

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Group II

laser therapy PROCEDURE

Undergo laser light photodynamic therapy

Also known as: therapy, laser

Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Pain; Skin Neoplasms

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Laser Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ilene L Rothman, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2014
• Last Updated: September 29, 2014

Record last verified: 2014-09

Locations

US (1)