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
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|ClinicalTrials.gov Identifier: NCT03678350|
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma Non-Small Cell Lung Carcinoma Pleural Disorder||Procedure: Light Dosimetry Procedure: Photodynamic Therapy Drug: Porfimer Sodium||Phase 1|
I. To demonstrate that our light dosimetry system is safe and effective in guiding intraoperative photodynamic therapy with porfimer sodium (Photofrin).
I. To evaluate progression free survival (PFS) and overall survival (OS). II. To examine the relationship between immune biomarkers and response.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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) With Pleural Disease - Phase I Study|
|Estimated Study Start Date :||December 30, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: Treatment (porfimer sodium, IO-PDT)
Participants receive porfimer sodium IV over 3-5 minutes and receive IO-PDT via a light dosimetry system 24-48 hours later.
Procedure: Light Dosimetry
Procedure: Photodynamic Therapy
Drug: Porfimer Sodium
- Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 30 days ]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.
- Progression-free survival [ 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 ]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.
- Overall survival (OS) [ Time Frame: From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years ]Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
- Anti tumor response [ Time Frame: Up to 2 years ]Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678350
|United States, New York|
|Roswell Park Cancer Institute||Not yet recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Ask RPCI 800-767-9355 ASKRPCI@roswellpark.org|
|Principal Investigator: Saikrishna S. Yendamuri|
|Principal Investigator:||Saikrishna Yendamuri||Roswell Park Cancer Institute|