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A Clinical Trial of ALA Photodynamic Therapy for Treatment of Actinic Cheilitis in Patients With Squamous Cell Carcinoma of the Lip.


Phase 4
18 Years
N/A
Not Enrolling
Both
Actinic Cheilitis, Squamous Cell Carcinoma In-situ (SCC-is), Squamous Cell Carcinoma (SCC), Photodynamic Therapy (PDT), Mohs Surgery

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Trial Information

A Clinical Trial of ALA Photodynamic Therapy for Treatment of Actinic Cheilitis in Patients With Squamous Cell Carcinoma of the Lip.


BACKGROUND:

SCC of the lip is commonly surrounded by extensive AC, which may affect part or all of the
lip vermillion. While Mohs surgical technique with complete margin control is the preferred
treatment for SCC at critical locations such as the lip, this technique is complicated by
surrounding AC. AC and SCC in situ at the tumor edge make it difficult to achieve margins
clear of dysplasia and as a result extra tissue beyond the invasive SCC often needs to be
excised to ensure that the entire tumor is removed.

Non-surgical treatments when used alone to treat SCC give lower cure rates than surgical
removal, and thus are not recommended as they place the subject at risk for recurrence and
metastatic disease. Although one study reported high SCC clearance rates with PDT alone
(24/25 SCCs histologically cleared), recurrence of 2 SCCs occurred and a metastasis to a LN
was seen in one patient. (Kubler et al.)

Given that PDT has been shown to have significant efficacy for actinic keratoses and actinic
cheilitis but is inadequate as primary treatment of lip SCC, we propose that PDT may be a
useful adjunct to surgical resection, allowing for less extensive surgery after the
dysplasia is addressed with PDT and potentially a lower recurrence rate. Although imiquimod
and 5-FU are also used to treat cutaneous dysplasia, many favor PDT treatment due to its
greater tolerability, shorter healing time, and more predictable host response.

There is significant data on the efficacy of PDT for treatment of actinic keratoses (AKs)
and PDT is now FDA approved for treatment of AKs. (Piacquadio et al). Data on PDT for
treatment of AC is much more limited, but small studies and case reports do indicate
successful treatment of AC with regimens utilizing either topical 5-aminolevulinic acid
(5-ALA), or a similar compound, methylaminopentanoate (MAL). The largest study with 5-ALA
reports complete clinical clearance in 13/19 patients treated with 1 to 3 treatments of ALA
plus Pulsed-dye laser (Alexiades). Sotiriou et al report that with two PDT treatments 8/10
patients had complete clinical and histologic clearance (Sotiriou). Case reports indicate
similar success (Kodama; Stender). Efficacy has also been shown with MAL PDT. One study
found that with two sessions of MAL + red light PDT complete histologic/ clinical clearance
was seen in 7/15 cases of AC and partial clearance was seen in an additional 7/15 (Berking
et al). Smaller studies and case reports have shown even higher response rates without
clinical recurrence during short-term follow-up (Rossi et al; Hauschild et al). We have
chosen 5-ALA plus blue light for PDT treatment in this study because it is FDA approved for
treatment of AKs and ALA is available in the United States.

Specific Aims:

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

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.

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- No exclusion based on gender or race

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

at time of Mohs

Safety Issue:

No

Principal Investigator

Gary Rogers, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center, Department of Dermatology

Authority:

United States: Institutional Review Board

Study ID:

PDT for Lip

NCT ID:

NCT00868088

Start Date:

July 2009

Completion Date:

September 2010

Related Keywords:

  • Actinic Cheilitis
  • Squamous Cell Carcinoma In-situ (SCC-is)
  • Squamous Cell Carcinoma (SCC)
  • Photodynamic Therapy (PDT)
  • Mohs Surgery
  • AC
  • SCC
  • SCC-is
  • PDT
  • Mohs
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Squamous Cell
  • Cheilitis

Name

Location

Tufts Medical Center, Department of DermatologyBoston, Massachusetts  02111