Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip

NCT00868088 | Completed Phase 4

• 1 other identifier: PDT for Lip
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Our study is designed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of actinic cheilitis (AC) and as an adjunct to Mohs surgery for squamous cell carcinoma (SCC) on the lips. This study will utilize an FDA approved PDT modality (DUSA, Inc., Wilmington, MA 01887) using topical 5-amino-levulinic acid (ALA) for photosensitization followed by exposure to a Blu-U light source emitting 405-420nm wavelength light.

Conditions

Actinic Cheilitis; Squamous Cell Carcinoma In-situ (SCC-is); Squamous Cell Carcinoma (SCC); Photodynamic Therapy (PDT); Mohs Surgery

Keywords

AC; SCC; SCC-is; PDT; Mohs

Outcome Measures

Primary Outcomes (1)

• To determine whether pre-operative treatment of the lips with ALA PDT can reduce the size of post-surgical defects (scars) in patients with AC and lip SCC.

  at time of Mohs

Secondary Outcomes (2)

• To determine whether ALA PDT applied to the lips can effectively clear actinic cheilitis (AC) and SCC in-situ (SCC-is) of the lip.

  at time of Mohs.

• To assess the tolerability of ALA PDT for treatment of AC and SCC-is of the lips

  at time of PDT and Mohs

Study Arms (2)

ALA + PDT

ACTIVE COMPARATOR

Topical ALA will be applied to the entire lip surface and allowed to incubate for 60 minutes plus or minus 30 minutes. Blue light at a wavelength of 405-420 nm will be used for treatment at a dose of 1000 seconds.

Procedure: PDT prior to Mohs surgery

placebo + PDT

PLACEBO COMPARATOR

Topical placebo will be applied to the entire lip surface and allowed to incubate for 60 minutes plus or minus 30 minutes. Blue light at a wavelength of 405-420 nm will be used for treatment at a dose of 1000 seconds.

Procedure: PDT prior to Mohs surgery

Interventions

PDT prior to Mohs surgery PROCEDURE

Day 1: Screening and consent for this study. If eligible, a scouting biopsy will be obtained at 1 cm from the clinical border of the SCC for confirmation of AC. 7-14 Days after consultation: PDT to all subjects in the study. If during treatment a subject requests to discontinue due to pain the treatment will be terminated. 3-5 weeks after consultation: return for assessment. At this visit, the assigned treatment may be repeated if the treatment site is adequately healed. Re-treatment will only occur if there is persistent actinic damage. 6-8 weeks after consultation: Mohs surgery will be performed as per routine. Following tumor removal a scouting biopsy will be taken at a site 1 cm from the wound site created by SCC removal. The current waiting time for non-urgent surgery is 8 weeks. Standard care is not being altered for subjects in the study, other then their receiving the PDT intervention. Photographs may be taken at each subject visit.

ALA + PDT; placebo + PDT

Eligibility Criteria

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

You may qualify if:

• Biopsy proven squamous cell carcinoma of the lip
• Greater than 50% of lip affected by actinic cheilitis by physical exam at time of initial evaluation.
• Patients \> 18 years of age
• Patients must be able to provide informed consent

You may not qualify if:

• Patients with history of photosensitivity
• Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease
• Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones)
• Patients with hypersensitivity to porphyrins.
• Women who are pregnant or nursing
• Patients who have received anti-neoplastic treatment such as imiquimod or 5-FU to the lips within 30 days of enrolling in this study.
• Patients simultaneously participating in another research study for management of SCC or actinic cheilitis
• Subjects that plan to use other forms of AC treatment prior to Mohs.
• Subjects that have an SCC requiring urgent (and sooner) Mohs surgery, including those tumors that are large (\> 2cm or at the discretion of the Principle Investigator) and those subjects that are pregnant or have palpable lymph nodes.

Sponsors & Collaborators

• Tufts Medical Center: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Tufts Medical Center, Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

Related Publications (7)

• Kubler AC, de Carpentier J, Hopper C, Leonard AG, Putnam G. Treatment of squamous cell carcinoma of the lip using Foscan-mediated photodynamic therapy. Int J Oral Maxillofac Surg. 2001 Dec;30(6):504-9. doi: 10.1054/ijom.2001.0160.

  PMID: 11829232 BACKGROUND

• Piacquadio DJ, Chen DM, Farber HF, Fowler JF Jr, Glazer SD, Goodman JJ, Hruza LL, Jeffes EW, Ling MR, Phillips TJ, Rallis TM, Scher RK, Taylor CR, Weinstein GD. Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials. Arch Dermatol. 2004 Jan;140(1):41-6. doi: 10.1001/archderm.140.1.41.

  PMID: 14732659 BACKGROUND

• Alexiades-Armenakas MR, Geronemus RG. Laser-mediated photodynamic therapy of actinic cheilitis. J Drugs Dermatol. 2004 Sep-Oct;3(5):548-51.

  PMID: 15552607 BACKGROUND

• Sotiriou E, Apalla Z, Koussidou-Erremonti T, Ioannides D. Actinic cheilitis treated with one cycle of 5-aminolaevulinic acid-based photodynamic therapy: report of 10 cases. Br J Dermatol. 2008 Jul;159(1):261-2. doi: 10.1111/j.1365-2133.2008.08607.x. Epub 2008 Jul 1. No abstract available.

  PMID: 18489592 BACKGROUND

• Stender IM, Wulf HC. Photodynamic therapy with 5-aminolevulinic acid in the treatment of actinic cheilitis. Br J Dermatol. 1996 Sep;135(3):454-6.

  PMID: 8949443 BACKGROUND

• Kodama M, Watanabe D, Akita Y, Tamada Y, Matsumoto Y. Photodynamic therapy for the treatment of actinic cheilitis. Photodermatol Photoimmunol Photomed. 2007 Oct;23(5):209-10. doi: 10.1111/j.1600-0781.2007.00299.x.

  PMID: 17803601 BACKGROUND

• Berking C, Herzinger T, Flaig MJ, Brenner M, Borelli C, Degitz K. The efficacy of photodynamic therapy in actinic cheilitis of the lower lip: a prospective study of 15 patients. Dermatol Surg. 2007 Jul;33(7):825-30. doi: 10.1111/j.1524-4725.2007.33176.x.

  PMID: 17598848 BACKGROUND

MeSH Terms

Conditions

Actinic cheilitis; Squamous Intraepithelial Lesions; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Gary Rogers, M.D.

  Tufts Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

US (1)