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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

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ClinicalTrials.gov Identifier: NCT03290677
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : February 23, 2021
Sponsor:
Collaborator:
William M. Wood Foundation
Information provided by (Responsible Party):
Meghan Jude Mooradian, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Cryoablation Procedure: Biopsy Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma

Arm Intervention/treatment
Experimental: CT-guided Percutaneous Cryoablation of Lung Tumor
  • 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
Procedure: Cryoablation
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.

Procedure: Biopsy
Removing a small piece of the affected area to confirm cancer




Primary Outcome Measures :
  1. Cumulative Incidence of Treatment Related Serious Adverse Events [ Time Frame: 2 years ]
    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).


Secondary Outcome Measures :
  1. Radiologic Response Rate Of Cryoablation [ Time Frame: 2 years ]

    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.



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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:

  • Adult patients (age > 18) with stage IV lung cancer receiving commercial supply immune checkpoint inhibitor therapy with progression of disease, and for whom an additional 4-6 weeks of current therapy (post-progression therapy) is acceptable as standard therapy
  • Must have a growing tumor amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria
  • Must have measurable disease (by RECIST) independent of the lesion to be ablated. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.

Exclusion Criteria:

  • Participants who are receiving an investigational agent(s)
  • 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 women are excluded from this study because immune checkpoint inhibitors have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with immune checkpoint inhibitors, breastfeeding should be discontinued.

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): NCT03290677


Contacts
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Contact: Meghan J Mooradian, MD 617-724-4000 MMOORADIAN@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Contact: Meghan J Mooradian, MD    617-724-4000    MMOORADIAN@mgh.harvard.edu   
Principal Investigator: Meghan J Mooradian, MD         
Sponsors and Collaborators
Massachusetts General Hospital
William M. Wood Foundation
Investigators
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Principal Investigator: Meghan J Mooradian, MD Massachusetts General Hospital
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Responsible Party: Meghan Jude Mooradian, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03290677    
Other Study ID Numbers: 17-264
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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