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Photodynamic Therapy in Treating Patients With Skin Cancer

Primary Purpose

Non-melanomatous Skin Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

aminolevulinic acid hydrochloride

conventional surgery

About this trial

This is an interventional treatment trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00002963

First Posted

November 1, 1999

Last Updated

January 30, 2013

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00002963

Brief Title

Photodynamic Therapy in Treating Patients With Skin Cancer

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

November 1993 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin, squamous cell carcinoma of the skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

aminolevulinic acid hydrochloride

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan R. Oseroff, MD, PhD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy in Treating Patients With Skin Cancer

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