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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

Malignant Mesothelioma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03678350
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 17, 2021
Completion date November 13, 2025
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