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 : Recruiting
First Posted : September 19, 2018
Last Update Posted : June 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma Non-Small Cell Lung Carcinoma Pleural Disorder||Device: Light Dosimetry for Intranoperative Therapy 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), or Other Malignancies With Pleural Disease - Phase I Study|
|Actual Study Start Date :||September 17, 2021|
|Estimated Primary Completion Date :||March 28, 2025|
|Estimated Study Completion Date :||March 28, 2025|
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.
Device: Light Dosimetry for Intranoperative Therapy
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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically confirmed malignant mesothelioma , non-small cell lung cancer (NSCLC) or other malignancies with pleural disease without distant disease.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2.
- Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after surgery. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- White blood cell (WBC) < 4,000.
- Platelet count < 100,000.
- Total serum bilirubin > 2 mg/dL.
- Serum creatinine > 2 mg/dL.
- Alkaline phosphatase > 3 times the upper normal limit.
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 3 times the upper normal limit.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing female subjects.
- Unwilling or unable to follow protocol requirements.
- Any condition which in the investigator?s opinion deems the subject an unsuitable candidate to receive porfimer sodium.
- Received an investigational agent within 30 days prior to enrollment.
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||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|
|Responsible Party:||Roswell Park Cancer Institute|
|Other Study ID Numbers:||
NCI-2018-01663 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 62118 ( Other Identifier: Roswell Park Cancer Institute )
|First Posted:||September 19, 2018 Key Record Dates|
|Last Update Posted:||June 21, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type