- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002963
Photodynamic Therapy in Treating Patients With Skin Cancer
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
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DS 92-42
- RPCI-DS-92-42
- NCI-V97-1191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-melanomatous Skin Cancer
-
National Cancer Institute (NCI)CompletedPrecancerous Condition | Non-melanomatous Skin CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedNon-melanomatous Skin Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedNon-melanomatous Skin CancerUnited States
-
Queen's Medical CenterCompletedNon-melanomatous Skin CancerUnited Kingdom
-
National Naval Medical CenterCompletedNon-melanomatous Skin CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedNon-melanomatous Skin Cancer
-
The Cleveland ClinicNational Cancer Institute (NCI)TerminatedNon-melanomatous Skin Cancer
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedNon-melanomatous Skin CancerUnited States
-
Baylor College of MedicineNational Cancer Institute (NCI)UnknownNon-Melanomatous Skin CancerUnited States
-
Laser and Skin Surgery Center of New YorkUnknownNon-melanomatous Skin CancerUnited States
Clinical Trials on aminolevulinic acid hydrochloride
-
Andrew Sloan, MDCompletedBrain and Central Nervous System TumorsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Precancerous ConditionUnited States
-
Laser and Skin Surgery Center of New YorkUnknownNon-melanomatous Skin CancerUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedLymphoma | LeukemiaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRefractory Mycosis FungoidesUnited States
-
Goldman, Butterwick, Fitzpatrick and GroffBiofrontera Bioscience GmbHNot yet recruitingSkin NeoplasmsUnited States
-
NX Development CorpActive, not recruitingMeningiomaUnited States, Austria, Germany
-
medac GmbHIKPCompleted
-
Fundación Instituto Valenciano de OncologíaUnknown
-
Johann Wolfgang Goethe University HospitalUnknownGlioma | Glioblastoma | Primary Malignant Neoplasm of Nervous System | MetastasisGermany