Roswell Park Phase1 Trial of Light Dosimetry System in NSCLCLight Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery Sponsors
Lead sponsor: Roswell Park Cancer Institute
Collaborator: National Cancer Institute (NCI)
Source Roswell Park Cancer Institute
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 or non-small cell lung cancer 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.
Overall Status Not yet recruiting
Start Date June 30, 2020
Completion Date August 1, 2021
Primary Completion Date August 1, 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Time Frame Up to 30 days
Secondary Outcome
Progression-free survival From time of surgery + photodynamic therapy (PDT) or, until start of a new treatment, disease progression or death (whichever occurs first), assessed up to 3 years
Overall survival (OS) From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years
Anti tumor response Up to 2 years
Enrollment 12