Photodynamic Therapy in Treating Patients With Skin Cancer

NCT ID: NCT00002963

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-11-30
• Study Completion Date: 2007-06-30

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.

Conditions

Non-melanomatous Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

aminolevulinic acid hydrochloride

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Allan R. Oseroff, MD, PhD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-DS-92-42

Identifier Type: -

Identifier Source: secondary_id

NCI-V97-1191

Identifier Type: -

Identifier Source: secondary_id

DS 92-42

Identifier Type: -

Identifier Source: org_study_id