Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 6
Summary
- Conditions
- 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
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: 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 ...
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. To assess the tumor response to treatment. II. To evaluate local progression-free survival (PFS). EXPLORATORY OBJECTIVES: I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship between immune biomarkers and response. OUTLINE: 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.
Tracking Information
- NCT #
- NCT03735095
- Collaborators
- National Cancer Institute (NCI)
- Pinnacle Biologics Inc.
- Investigators
- Principal Investigator: Nathaniel Ivanick, MD Roswell Park Cancer Institute
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