Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002975
Status:
COMPLETED
Last Update Posted:
2013-10-10
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:
A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20 Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 may be effective in treating patients with skin cancer
PURPOSE This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer
PURPOSE This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions
OUTLINE This is a randomized study Patients are stratified according to lesion type superficial basal cell carcinoma BCC vs nodular BCC vs superficial squamous cell carcinoma vs actinic keratoses Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid ALA
ALA is topically applied in a cream mixture and an occlusive dressing is placed over the lesion After the randomized duration of ALA application has expired the dressing is removed and a dye laser is used to treat the lesion
Patients are followed for 2-5 years after treatment
PROJECTED ACCRUAL Up to 200 patients could be accrued assuming 1 lesion per patient 50 lesions are required for each stratified group
Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions
OUTLINE This is a randomized study Patients are stratified according to lesion type superficial basal cell carcinoma BCC vs nodular BCC vs superficial squamous cell carcinoma vs actinic keratoses Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid ALA
ALA is topically applied in a cream mixture and an occlusive dressing is placed over the lesion After the randomized duration of ALA application has expired the dressing is removed and a dye laser is used to treat the lesion
Patients are followed for 2-5 years after treatment
PROJECTED ACCRUAL Up to 200 patients could be accrued assuming 1 lesion per patient 50 lesions are required for each stratified group
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-G97-1224 | None | None | None |
| RPCI-DS-96-55 | None | None | None |