Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002963
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Brief Title:
Photodynamic Therapy in Treating Patients With Skin Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1191 | None | None | None |
| RPCI-DS-92-42 | None | None | None |