Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Pleural Diseases

Mesothelioma

Mesothelioma, Malignant

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Malignant Mesothelioma

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Ether

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Photosensitizing Agents

Participants receive porfimer sodium IV over 3-5 minutes and receive IO-PDT via a light dosimetry system 24-48 hours later.

Light Dosimetry for Intranoperative Therapy

Photodynamic Therapy

Porfimer Sodium

Saikrishna Yendamuri

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.

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

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

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.

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.

Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.

Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence

Lumeda,Inc.

Roswell Park Cancer Institute

Immunomodulating Agents

Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

Video-Assisted Thoracic Surgery

Subjects will receive one course of light therapy at the time of surgery

Intraoperative PDT

ASK Roswell

Saikrishna S. Yendamuri

• Saikrishna Yendamuri, MD

This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease. Photodynamic therapy is a technique that that works by combining a photosensitizing agent (porfimer sodium in this trial) and an intense light source to kill tumor cells. Photodynamic therapy may decrease the patients' symptoms and improve their quality of life.

Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease

Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease or Malignant Pleural Mesothelioma (MPM) - Phase I Study

Will be determined by recording the occurrence of SAE during the first 28 days post study-related immunotherapy. The SAE will be evaluated using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.

Will be analyzed using a repeated measures analysis-of-variance (ANOVA) model with a factor for dose level time and a dose level by time interaction.

Will be analyzed using a repeated measures ANOVA model with a factor for dose level, time and a dose level by time interaction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT03678350	Malignant Mesot... Non-Small Cell ... Pleural Disorde...	Light Dosimetry... Photodynamic Th... Porfimer Sodium	18 Years -	Roswell Park Cancer Institute
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	NCT03678350	Malignant Mesot... Non-Small Cell ... Pleural Disorde...	Light Dosimetry... Photodynamic Th... Porfimer Sodium	18 Years -	Roswell Park Cancer Institute
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	NCT03678350	Malignant Mesot... Non-Small Cell ... Pleural Disorde...	Light Dosimetry... Photodynamic Th... Porfimer Sodium	18 Years -	Roswell Park Cancer Institute
Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease	NCT04836429	Lung Non-Small ... Pleural Disorde...	Porfimer Sodium Video-Assisted ... Photodynamic Th... Intraoperative ...	18 Years -	Roswell Park Cancer Institute
Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease	NCT04836429	Lung Non-Small ... Pleural Disorde...	Porfimer Sodium Video-Assisted ... Photodynamic Th... Intraoperative ...	18 Years -	Roswell Park Cancer Institute

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