Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03735095|
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Lung Carcinoma Non-Small Cell Lung Carcinoma Small Cell Lung Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8||Drug: Porfimer Sodium Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy||Phase 1 Phase 2|
PRIMARY OBJECTIVES PHASE 1:
I. To evaluate the safety and potential efficacy of endobronchial ultrasound with transbronchial needle (EBUS-TBN) guided interstitial photodynamic therapy (EBUS-TBN I-PDT) and/or I-PDT and/or photodynamic therapy (PDT) in patients with locally advanced lung cancer (LALC) in the central airway, using porfimer sodium as a photosensitizer.
PRIMARY OBJECTIVE Phase II
- I. To assess the tumor response to treatment.
- II To observe changes in well being
- I. To evaluate local progression-free survival (PFS).
- II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™
I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship between immune biomarkers and response.
Patients receive Porfimer sodium intravenously (IV) over 20 minutes 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.
After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endobronchial Ultrasound Transbronchial Needle Guided Interstitial Photodynamic Therapy for Palliation of Locally Advanced Lung Cancer and Advanced Cancers Obstructing the Airway -Phase I/IIa|
|Actual Study Start Date :||February 4, 2020|
|Estimated Primary Completion Date :||February 4, 2022|
|Estimated Study Completion Date :||February 4, 2022|
Experimental: Treatment (porfimer sodium, EBUS, and photodynamic therapy)
Patients receive porfimer sodium IV over 20 minutes 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.
Drug: Porfimer Sodium
Other Name: Photofrin
Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Undergo EBUS-TBN guided I-PDT
- Incidence of adverse events that are >= grade 4 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 [ Time Frame: Up to 4 weeks ]
- Tumor response rate - Phase II study [ Time Frame: up to 24 weeks ]Will be reported using frequencies and relative frequencies
- Progression-free survival (PFS) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks ]Will be summarized using standard Kaplan-Meier methods, with median PFS and specified PFS rates estimated with 95% confidence intervals.
- Porfimer sodium retention in the target tumor tissue [ Time Frame: Up to 24 weeks ]Will be descriptively summarized with mean +/- standard deviations.
- Immune biomarkers measured with Spearman rank correlation [ Time Frame: Up to 24 weeks ]Will examine the relationship between immune biomarkers and response. Will correlate immune biomarkers and tumor response measures using the Spearman rank correlation and corresponding 95% confidence interval.
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): NCT03735095
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Nathaniel Ivanick, MD 716-845-8675 Nathaneil.Ivanick@RoswellPark.org|
|Principal Investigator: Nathanel Ivanick, MD|
|Principal Investigator:||Nathaniel Ivanick, MD||Roswell Park Cancer Institute|