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Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

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Trial Information

Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy


OBJECTIVES:

- Characterize the penetration of topically applied aminolevulinic acid (ALA) into the
lesions of patients with primary basal cell and squamous cell carcinomas.

- Quantitate the depth of fluorescence achievable with varying application periods of ALA
in these patients.

- Compare the results of tissue fluorescence with surface fluorescence measurements in
these patients.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type
(superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients
within each group are randomized to receive one of two application times: 4-5 or 20-24 hours
in duration.

Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an
occlusive dressing placed over the lesion. After the randomized treatment duration has
expired, the dressing is removed and quantitative protoporphyrin IX fluorescence
measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine
surgical excision is then performed on the carcinoma.

Patients return after one to two weeks for a follow-up examination and suture removal.

PROJECTED ACCRUAL: 54 patients will be accrued within 10 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven basal cell carcinoma or squamous cell carcinoma

- Candidate for complete surgical excision

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No inflammation or infection of treated area

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Biopsy at least 2 weeks prior to surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX

Safety Issue:

No

Principal Investigator

Allan R. Oseroff, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

DS 92-42

NCT ID:

NCT00002963

Start Date:

November 1993

Completion Date:

June 2007

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263