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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Cryoablation Procedure: Biopsy||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: CT-guided Percutaneous Cryoablation of Lung Tumor
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.
Removing a small piece of the affected area to confirm cancer
- 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).
- 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.
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
|Contact: Meghan J Mooradian, MD||617-724-4000||MMOORADIAN@mgh.harvard.edu|
|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|
|Principal Investigator:||Meghan J Mooradian, MD||Massachusetts General Hospital|