A Phase 1 interventional study of Light Dosimetry for Intranoperative Therapy and Photodynamic Therapy in Malignant Mesothelioma, Non-Small Cell Lung Carcinoma and Pleural Disorder, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Roswell Park Cancer Institute · Phase 1, Interventional, and Treatment
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.
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.
409 studies on the registry are indexed under Mesothelioma, Malignant; 71 are open to participants now.
This study's enrollment of 9 is below the median of 37 across 329 interventional studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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Exclusion Criteria:
Participants receive porfimer sodium IV over 3-5 minutes and receive IO-PDT via a light dosimetry system 24-48 hours later.
Device: Light Dosimetry for Intranoperative Therapy · Procedure: Photodynamic Therapy · Drug: Porfimer Sodium
Undergo IO-PDT
Undergo IO-PDT
Also known as: PDT, Photoradiation Therapy
Given IV
Also known as: CL-184116, DHE, Dihematoporphyrin Ester, dihematoporphyrin ether, Photofrin II
Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
Time frame: Up to 30 days
Progression-free survival
The estimated distribution of progression free survival will be obtained using the Kaplan-Meier method. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Time frame: 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)
Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Time frame: From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years
Anti tumor response
Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence
Time frame: Up to 2 years
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute