Lung CancerNCT03290677
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
A study testing Cryoablation and Biopsy in people with Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Cryoablation and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
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
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- Cryoablation, Biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
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.
BiopsyProcedure or surgery
Removing a small piece of the affected area to confirm cancer
| Study group | Role | What they receive |
|---|---|---|
| CT-guided Percutaneous Cryoablation of Lung Tumor | Experimental | * 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 Receives: Procedure: Cryoablation; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Treatment Related Serious Adverse Events
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).
Measured: 2 years
Radiologic Response Rate Of Cryoablation
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start17 Jan 2018
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- William M. Wood Foundation
- Responsible party
- Principal investigator, Meghan Mooradian, Massachusetts General Hospital
- Investigators
- Meghan J Mooradian, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290677
- Sponsor's protocol ID
- 17-264
- Status last verified
- Mar 2024
- First submitted
- 11 Sep 2017
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mooradian MJ, Fintelmann FJ, LaSalle TJ, Simon J, Graur A, Muzikansky A, Mino-Kenudson M, Shalhout S, Kaufman HL, Jenkins RW, Lawrence D, Lawless A, Sharova T, Uppot RN, Fang J, Blaum EM, Gonye ALK, Gushterova I, Boland GM, Azzoli C, Hacohen N, Sade-Feldman M, Sullivan RJ. Cryoablation and post-progression immune checkpoint inhibition in metastatic melanoma: a phase II trial. Nat Commun. 2024 Aug 27;15(1):7357. doi: 10.1038/s41467-024-51722-x.
PubMed 39191779
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03290677
- Acronym / sponsor ID
- 17-264
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- William M. Wood Foundation
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-guided Percutaneous Cryoablation of Lung Tumor | Experimental | Procedure: Cryoablation, Procedure: Biopsy* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationThis 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 or surgery | CT-guided Percutaneous Cryoablation of Lung Tumor |
| BiopsyRemoving a small piece of the affected area to confirm cancer | Procedure or surgery | CT-guided Percutaneous Cryoablation of Lung Tumor |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 39191779Mooradian MJ, Fintelmann FJ, LaSalle TJ, Simon J, Graur A, Muzikansky A, Mino-Kenudson M, Shalhout S, Kaufman HL, Jenkins RW, Lawrence D, Lawless A, Sharova T, Uppot RN, Fang J, Blaum EM, Gonye ALK, Gushterova I, Boland GM, Azzoli C, Hacohen N, Sade-Feldman M, Sullivan RJ. Cryoablation and post-progression immune checkpoint inhibition in metastatic melanoma: a phase II trial. Nat Commun. 2024 Aug 27;15(1):7357. doi: 10.1038/s41467-024-51722-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan J Mooradian, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and Biopsy in people with Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Treatment Related Serious Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.