NCT03735095

Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer

Endobronchial Ultrasound Transbronchial Needle Guided Interstitial Photodynamic Therapy for Palliation of Locally Advanced Lung Cancer and Advanced Cancers Obstructing the Airway -Phase I/II

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I/Il studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes. Photodynamic therapy consists of injecting a light sensitive drug called a photosensitizer, such as porfimer sodium, into the vein, waiting for it to accumulate in the tumor, and then activating it with a red laser light. Giving photodynamic therapy with Porfimer sodium may reduce the tumor size in patients with lung cancer.

Detailed description

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 malignant airway obstructions 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 SECONDARY OBJECTIVES: * I. To evaluate local progression-free survival (PFS). * II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™ - COHORT A ONLY * III. To measure changes in tumor pO2, optical properties, and irradiance and fluence in relationship to response 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 delivery of I-PDT. 20 minutes 48 hours +/- 4 hours before receiving I-PDT. I-PDT is then received over 1-2 hours. After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.

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
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Porfimer Sodium	Given IV
PROCEDURE	Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy	Undergo EBUS-TBN guided I-PDT

Timeline

• Start date: 2020-02-12
• Primary completion: 2024-07-26
• Completion: 2024-07-26
• First posted: 2018-11-08
• Last updated: 2025-04-16
• Results posted: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study