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Bronchoscopic Cryo-Immunotherapy of Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049474
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a safety and feasibility study of bronchoscopic cryo-immunotherapy (BCI) of peripheral lung tumors in advanced non-small cell lung cancer for the intention of inducing anti-tumor immune responses. The sample size for this study will be 15 patients. Pre- and post- BCI peripheral blood samples will be analyzed to assess for anti-tumor immune responses. Post-BCI peripheral blood will be collected 7 and 14 days after the procedure.

Condition or disease Intervention/treatment Phase
Advanced Non-small Cell Lung Cancer Device: ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bronchoscopic Cryo-Immunotherapy (BCI)
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
Device: ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)
See BCI description.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 1 Day ]
    1. Successful performance in at least 80% of patients in whom BCI is attempted. This will require identification of the target peripheral lung tumor by radial endobronchial ultrasound within 20 minutes followed by completed cryoablation of target tumor.

  2. Safety [ Time Frame: 7 Days ]
    1. Incidence of bleeding complications
    2. Incidence of pneumothorax
    3. Incidence of NCI Common Terminology Criteria for Adverse Events (CTCAE) grade 3, 4, or 5 adverse events which may be possibly, probably, or definitely related to BCI
    4. Maximum tolerated dose (ie, freeze time)


Secondary Outcome Measures :
  1. Ability of radial endobronchial ultrasound to identify peripheral lung tumor [ Time Frame: 1 Day ]
  2. Length of time to perform BCI [ Time Frame: 1 Day ]
  3. Length of fluoroscopy exposure during BCI [ Time Frame: 1 Day ]
  4. Pre- and Post-BCI peripheral blood analysis [ Time Frame: 14 Days ]
  5. Correlation of BAL PD-1 phenotype with peripheral blood [ Time Frame: 14 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripheral lung tumor on pre-procedure chest CT scan, which is known or suspected to be advanced, inoperable non-small cell lung cancer (stages IIIA/B/C and IVA/B) based on the 8th edition TNM staging guidelines
  • Pre-procedure chest CT scan with the presence of a bronchus or airway path leading directly to the peripheral lung tumor (also known as a "bronchus sign")
  • Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study.
  • Documentation of non-small cell lung cancer either prior to procedure or via on-site pathology review during bronchoscopy (prior to proceeding with planned BCI)
  • Ability to provide informed consent
  • Concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed
  • ECOG performance status less than or equal to 2

Exclusion Criteria:

  • Pregnancy
  • Currently on a platelet inhibitor (such as Clopidogrel) other than aspirin or NSAIDS, or on a blood thinner (such as heparin, enoxaparin, or a novel oral anticoagulant), which is unable to be held for planned bronchoscopy
  • INR >= 1.5 (post correction)
  • Platelets =< 100,000 (post correction)
  • Bleeding diathesis
  • Contraindication to bronchoscopy
  • Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.

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): NCT04049474


Contacts
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Contact: Ashley Witzl (212) 263-1208 Ashley.Witzl@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Ashley Witzl    212-263-1208    Ashley.Witzl@nyulangone.org   
Principal Investigator: Daniel Sterman, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Daniel Sterman, MD New York Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04049474    
Other Study ID Numbers: 17-00812
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases