Buffalo, New York 14263

  • melanomatous Skin Cancer

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

DS 92-42


NCT ID:

NCT00002963


Secondary ID:

RPCI-DS-92-42


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Roswell Park Cancer Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Primary Purpose: Treatme


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Allan R. Oseroff, MD, PhD
Study Chair
Roswell Park Cancer Institute

Study Dates

Start Date:November 1993
Completion Date:June 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 30, 2013
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:aminolevulinic acid hydrochloride
Intervention Type:Procedure
Name:conventional surgery

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Roswell Park Cancer Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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