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OpenTrials
Completed

NCT Number: NCT00002963

Photodynamic Therapy in Treating Patients With Skin Cancer

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminolevulinic Acid Hydrochloride

Drug

conventional surgery

Procedure

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
2007
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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