Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 6:10 PM
Study NCT ID:
NCT03678350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-11
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Light Dosimetry for Intraoperative Photodynamic Therapy (IO-PDT) With Porfimer Sodium (Photofrin) in Patients With Malignant Mesothelioma or Non-Small Cell Lung Cancer (NSCLC), or Other Malignancies With Pleural Disease - Phase I Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating participants with malignant mesothelioma , non-small cell lung cancer or any other malignancy with pleural disease undergoing surgery. Light dosimetry measures the amount of laser light given during photodynamic therapy. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to light. The activated drug may kill tumor cells. Using light dosimetry for intraoperative photodynamic therapy may help doctors estimate how much light is delivered during photodynamic therapy and decide if the treatment should be stopped or continued.
Detailed Description:
PRIMARY OBJECTIVES:
I. To demonstrate that our light dosimetry system is safe and effective in guiding intraoperative photodynamic therapy with porfimer sodium (Photofrin).
SECONDARY OBJECTIVES:
I. To evaluate progression free survival (PFS) and overall survival (OS). II. To examine the relationship between immune biomarkers and response.
OUTLINE:
Participants receive porfimer sodium intravenously (IV) over 3-5 minutes and receive intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system 24-48 hours later.
After conclusion of study treatment, participants are followed up at 30 days, within 4 weeks from surgery and PDT and every 6 months for 2 years.
I. To demonstrate that our light dosimetry system is safe and effective in guiding intraoperative photodynamic therapy with porfimer sodium (Photofrin).
SECONDARY OBJECTIVES:
I. To evaluate progression free survival (PFS) and overall survival (OS). II. To examine the relationship between immune biomarkers and response.
OUTLINE:
Participants receive porfimer sodium intravenously (IV) over 3-5 minutes and receive intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system 24-48 hours later.
After conclusion of study treatment, participants are followed up at 30 days, within 4 weeks from surgery and PDT and every 6 months for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: