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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pinnacle Biologics Inc.
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This Phase I/Ila 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.

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

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 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

SECONDARY OBJECTIVES:

  • I. To evaluate local progression-free survival (PFS).
  • II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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
Given IV
Other Name: 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




Primary Outcome Measures :
  1. 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 ]
  2. Tumor response rate - Phase II study [ Time Frame: up to 24 weeks ]
    Will be reported using frequencies and relative frequencies


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Porfimer sodium retention in the target tumor tissue [ Time Frame: Up to 24 weeks ]
    Will be descriptively summarized with mean +/- standard deviations.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
  • Patients with a diagnosis of small cell and/or non-small cell lung cancer or other malignancy that metastasize to the lung causing airway obstruction > 25% requiring bronchoscopic intervention
  • 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 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 study drug.

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Pinnacle Biologics Inc.
Investigators
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Principal Investigator: Nathaniel Ivanick, MD Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03735095    
Other Study ID Numbers: I 279415
NCI-2018-01969 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 279415 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021

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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
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents