Clinical Trials /

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

NCT04049474

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Bronchoscopic Cryo-Immunotherapy of Lung Cancer
  • Official Title: Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17-00812
  • NCT ID: NCT04049474

Conditions

  • Advanced Non-small Cell Lung Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Bronchoscopic Cryo-Immunotherapy (BCI)ExperimentalBCI 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.

    Eligibility 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.
          
    Maximum Eligible Age:80 Years
    Minimum Eligible Age:22 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Feasibility
    Time Frame:1 Day
    Safety Issue:
    Description: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.

    Secondary Outcome Measures

    Measure:Ability of radial endobronchial ultrasound to identify peripheral lung tumor
    Time Frame:1 Day
    Safety Issue:
    Description:
    Measure:Length of time to perform BCI
    Time Frame:1 Day
    Safety Issue:
    Description:
    Measure:Length of fluoroscopy exposure during BCI
    Time Frame:1 Day
    Safety Issue:
    Description:
    Measure:Pre- and Post-BCI peripheral blood analysis
    Time Frame:14 Days
    Safety Issue:
    Description:
    Measure:Correlation of BAL PD-1 phenotype with peripheral blood
    Time Frame:14 Days
    Safety Issue:
    Description:

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:NYU Langone Health

    Last Updated

    August 20, 2020