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

NCT03735095 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: I 279415NCI-2018-019691R44CA265656
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Progression-free Survival (PFS) Assessed Using Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria

  From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks

Study Arms (1)

Treatment (porfimer sodium, EBUS, and photodynamic therapy)

EXPERIMENTAL

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; Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy

Interventions

Porfimer Sodium DRUG

Given IV

Also known as: Photofrin

Treatment (porfimer sodium, EBUS, and photodynamic therapy)

Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy PROCEDURE

Undergo EBUS-TBN guided I-PDT

Also known as: 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

Treatment (porfimer sodium, EBUS, and photodynamic therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Pinnacle Biologics Inc.: collaborator
• Simphotek Inc.: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Dihematoporphyrin Ether

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Comprehensive Cancer Center

Adrienne.Groman@RoswellPark.org

716-845-2300

Study Officials

• Nathaniel Ivanick, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: February 12, 2020
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Locations

US (1)