<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03290677</url>
  </required_header>
  <id_info>
    <org_study_id>17-264</org_study_id>
    <nct_id>NCT03290677</nct_id>
  </id_info>
  <brief_title>Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Metastatic Lung Cancer and Metastatic Melanoma Receiving Post-progression Immune Checkpoint Inhibitor Therapy</brief_title>
  <official_title>A Phase II Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Metastatic Lung Cancer and Metastatic Melanoma Receiving Post-progression Immune Checkpoint Inhibitor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>William M. Wood Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is studying cryoablation (a treatment to kill cancer cells with extreme&#xD;
      cold) combined with continued treatment with current immune checkpoint inhibitor as a&#xD;
      possible treatment for lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety&#xD;
      and effectiveness of an investigational intervention to learn whether the intervention works&#xD;
      in treating a specific disease. &quot;Investigational&quot; means that the intervention is being&#xD;
      studied.&#xD;
&#xD;
      The FDA (the U.S. Food and Drug Administration) has approved each aspect of this therapy,&#xD;
      however this research study is unique because it combines them as a treatment option for the&#xD;
      participant's disease. That has not been approved by the FDA.&#xD;
&#xD;
      In this research study, The investigators are...&#xD;
&#xD;
        -  Continuing the participant on the participant's immune checkpoint inhibitor therapy even&#xD;
           though the participant's doctor believes that the participant's cancer is growing. Since&#xD;
           the participant's cancer is growing, there is only a small chance the participant will&#xD;
           respond to continued drug therapy.&#xD;
&#xD;
        -  Taking a biopsy of the participant's cancer to confirm there is cancer growing in the&#xD;
           location to be treated.&#xD;
&#xD;
        -  Performing cryoablation on an enlarging tumor. This involves passing a special needle&#xD;
           into the participant's body (cryoprobe) to freeze tumor and kill a small part (not all)&#xD;
           of the participant's cancer. Your immune system will respond to the damage caused by&#xD;
           freezing part of the participant's tumor.&#xD;
&#xD;
        -  The investigators are hoping to demonstrate that combining post-progression immune&#xD;
           checkpoint inhibitor therapy with cryoablation is safe, and may induce and/or restore an&#xD;
           immune response to cancer in other places in the participant's body&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative Incidence of Treatment Related Serious Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>The safety and feasibility of the procedure will be determined based on observed adverse events. Cryoablation will be determined safe and feasible to implement in this study population if the cumulative incidence of serious adverse events (SAE) related to cryoablation is no higher than 20%. Adverse events are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiologic Response Rate Of Cryoablation</measure>
    <time_frame>2 years</time_frame>
    <description>The number of participants that achieve a complete response (CR) or partial response (PR) following cryoablation.&#xD;
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>CT-guided Percutaneous Cryoablation of Lung Tumor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Image-guided core needle biopsy to confirm cancer will be perform&#xD;
Patients will undergo cryoablation as a standard procedure&#xD;
cryoablation will be performed with a three-cycle freeze-thaw phase protocol&#xD;
Non-contrast CT images will be obtained in 3 to 5 minutes intervals to visualize the evolving ablation zone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryoablation</intervention_name>
    <description>This involves passing a special needle into the body (cryoprobe) to freeze tumor and kill a small part (not all) of the cancer. The immune system will respond to the damage caused by freezing part of the tumor.</description>
    <arm_group_label>CT-guided Percutaneous Cryoablation of Lung Tumor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy</intervention_name>
    <description>Removing a small piece of the affected area to confirm cancer</description>
    <arm_group_label>CT-guided Percutaneous Cryoablation of Lung Tumor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age &gt; 18) with stage IV lung cancer receiving commercial supply immune&#xD;
             checkpoint inhibitor therapy with progression of disease, and for whom an additional&#xD;
             4-6 weeks of current therapy (post-progression therapy) is acceptable as standard&#xD;
             therapy&#xD;
&#xD;
          -  Must have a growing tumor amenable to percutaneous image-guided cryoablation based on&#xD;
             routine Interventional Radiology criteria&#xD;
&#xD;
          -  Must have measurable disease (by RECIST) independent of the lesion to be ablated.&#xD;
             Measurable disease is defined as at least one lesion that can be accurately measured&#xD;
             in at least one dimension (longest diameter to be recorded for non-nodal lesions and&#xD;
             short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with&#xD;
             spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation&#xD;
             of measurable disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are receiving an investigational agent(s)&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Pregnant women are excluded from this study because immune checkpoint inhibitors have&#xD;
             the potential for teratogenic or abortifacient effects. Because there is an unknown&#xD;
             but potential risk for adverse events in nursing infants secondary to treatment of the&#xD;
             mother with immune checkpoint inhibitors, breastfeeding should be discontinued.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meghan J Mooradian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meghan J Mooradian, MD</last_name>
    <phone>617-724-4000</phone>
    <email>MMOORADIAN@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02214</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meghan J Mooradian, MD</last_name>
      <phone>617-724-4000</phone>
      <email>MMOORADIAN@mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Meghan J Mooradian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Meghan Jude Mooradian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290677
org study id: 17-264
nct id: NCT03290677
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study is studying cryoablation (a treatment to kill cancer cells with extreme
      cold) combined with continued treatment with current immune checkpoint inhibitor as a
      possible treatment for lung cancer.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational intervention to learn whether the intervention works
      in treating a specific disease. "Investigational" means that the intervention is being
      studied.

      The FDA (the U.S. Food and Drug Administration) has approved each aspect of this therapy,
      however this research study is unique because it combines them as a treatment option for the
      participant's disease. That has not been approved by the FDA.

      In this research study, The investigators are...

        -  Continuing the participant on the participant's immune checkpoint inhibitor therapy even
           though the participant's doctor believes that the participant's cancer is growing. Since
           the participant's cancer is growing, there is only a small chance the participant will
           respond to continued drug therapy.

        -  Taking a biopsy of the participant's cancer to confirm there is cancer growing in the
           location to be treated.

        -  Performing cryoablation on an enlarging tumor. This involves passing a special needle
           into the participant's body (cryoprobe) to freeze tumor and kill a small part (not all)
           of the participant's cancer. Your immune system will respond to the damage caused by
           freezing part of the participant's tumor.

        -  The investigators are hoping to demonstrate that combining post-progression immune
           checkpoint inhibitor therapy with cryoablation is safe, and may induce and/or restore an
           immune response to cancer in other places in the participant's body
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative Incidence of Treatment Related Serious Adverse Events
time frame: 2 years
description: The safety and feasibility of the procedure will be determined based on observed adverse events. Cryoablation will be determined safe and feasible to implement in this study population if the cumulative incidence of serious adverse events (SAE) related to cryoablation is no higher than 20%. Adverse events are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
measure: Radiologic Response Rate Of Cryoablation
time frame: 2 years
description: The number of participants that achieve a complete response (CR) or partial response (PR) following cryoablation.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
arm group label: CT-guided Percutaneous Cryoablation of Lung Tumor
arm group type: Experimental
description: Image-guided core needle biopsy to confirm cancer will be perform
Patients will undergo cryoablation as a standard procedure
cryoablation will be performed with a three-cycle freeze-thaw phase protocol
Non-contrast CT images will be obtained in 3 to 5 minutes intervals to visualize the evolving ablation zone
intervention type: Procedure
intervention name: Cryoablation
description: This involves passing a special needle into the body (cryoprobe) to freeze tumor and kill a small part (not all) of the cancer. The immune system will respond to the damage caused by freezing part of the tumor.
arm group label: CT-guided Percutaneous Cryoablation of Lung Tumor
intervention type: Procedure
intervention name: Biopsy
description: Removing a small piece of the affected area to confirm cancer
arm group label: CT-guided Percutaneous Cryoablation of Lung Tumor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Meghan J Mooradian, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Meghan J Mooradian, MD
phone: 617-724-4000
email: MMOORADIAN@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Meghan Jude Mooradian
investigator title: Principal Investigator
mesh term: Lung Neoplasms
sharing ipd: No