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

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Carcinoma; Solid Tumor; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Non-Small Cell Lung Carcinoma; Locally Advanced Lung Carcinoma
• Intervention / Treatment: Drug: Porfimer Sodium; Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• > 18 year olds
• Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
• For patients in Cohort B only. Patients are amenable to receive a palliative radiotherapy of 8 Gy x1 48±4 h prior to the I-PDT, as determined by the radiation oncologist
• Patients with an established pathologic diagnosis of small cell and/or non-small cell lung cancer or other malignancies causing airway obstruction > 25% requiring bronchoscopic intervention. Or inoperable malignancies not candidates for curative radiotherapy within the airway.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
• Platelets >= 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L).
• Participants 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. 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.
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

• Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT.
• 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 participants.
• Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment.
• Known hypersensitivity/allergy to porphyrin.
• Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia.
• Patients with target tumor invading into the lumen of the esophagus, confirmed by esophago-gastro-duodenoscopy (EGD) with endoscopic ultrasound
• Patients diagnosed with porphyria.
• Unwilling or unable to follow protocol requirements.
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive I-PDT or PDT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (porfimer sodium, EBUS, and photodynamic therapy); Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.

Drug: Porfimer Sodium; Given IV; Other Names: Photofrin; Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy; Undergo EBUS-TBN guided I-PDT; Other Names: Endobronchial Ultrasound with Transbronchial Needle (EBUS-TBN) Guided Interstitial PDT (IPDT); Endobronchial Ultrasound Transbronchial Needle-Guided Interstitial Photodynamic Therapy; Ultrasound-Guided Transbronchial Needle-Guided Interstitial Photodynamic Therapy; EBUS-TBN Interstitial Photodynamic Therapy; EBUS-TBN IPDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0	Number of Participants with Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0	Up to 4 weeks
Number of Participants With Tumor Response	Will be reported using frequencies	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Assessed Using Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria	Will be summarized using standard Kaplan-Meier methods, with median progression-free survival (PFS) estimated with 95% confidence intervals. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Porfimer sodium retention in the target tumor tissue	Will be descriptively summarized with mean +/- standard deviations.	Up to 24 weeks
Immune biomarkers measured with Spearman rank correlation	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.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI); Pinnacle Biologics Inc.; Simphotek Inc.
• Investigators: Principal Investigator: Nathaniel Ivanick, MD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Pigments, Biological; Biological Factors; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Pyrroles; Macrocyclic Compounds; Porphyrins; Tetrapyrroles; Hematoporphyrin Derivative; Hematoporphyrins; Dihematoporphyrin Ether
• Other Study ID Numbers: I 279415 (Other Identifier: Roswell Park Cancer Institute); NCI-2018-01969 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 1R44CA265656 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No