Lung MetastasesPhase 1NCT04200417
Chemoembolization for Lung Tumors
A Phase 1 study testing Chemoembolization, Mitomycin C and Lipiodol in people with Lung Metastases and Endobronchial Metastases, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
This study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Metastases, Endobronchial Metastases, Pleural Metastases
- What is being tested?
- Chemoembolization, Mitomycin C and Lipiodol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Dec 2019to 19 Apr 2022
- Phase
- Phase 1
- 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
- Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or SBRT.
- At least 18 years old.
- ECOG performance status 0 or 1
Who cannot join
- Primary lung cancer
- >50% of a lung is replaced with tumor
- Oxygen saturation <92% on room air
- FEV1 <60%
- Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, MRI, or direct pressure measurement)
- Recent pulmonary embolism (within 3 months)
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- Pulmonary arteriovenous malformation
- Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
- Symptomatic heart failure (dyspnea, volume overload)
- Left bundle branch block (contraindication to pulmonary angiography)
- Renal failure (eGFR <30 mL/min/1.73m^2)
- Pregnancy
- Breastfeeding
- Altered mental status that would interfere with consent or follow-up
- Platelets < 100,000 (after transfusion, if needed)
- INR>2 (after transfusion, if needed)
- Hemoglobin <7 (after transfusion, if needed)
- Hyperthyroidism (contraindication to lipiodol)
- Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
- Allergy to lipiodol or mitomycin
- Allergy to iodinated contrast that can not be treated with steroid / diphenhydramine premedication
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase I Study of Transarterial Chemoembolization of Lung Metastases
This study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.
- Being tested
- Chemoembolization, Mitomycin C, Lipiodol, Embospheres
- Keywords
- Unresectable Lung Cancer, Unresectable Endobronchial Mestastases, Unresectable Pleural Metastases, Unresectable Mediastinal Metastases, Lung Chemoembolization, 19-371, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoembolizationProcedure or surgery
Chemoembolization will be performed via the artery (bronchial, non-bronchial systemic, or pulmonary) that shows the greatest tumor enhancement on angiography. Chemoembolization will be performed using a lipiodol / mitomycin emulsion, followed by spherical particles.
Mitomycin CDrug
Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
LipiodolDrug
Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
EmbospheresDrug
Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.
| Study group | Role | What they receive |
|---|---|---|
| Lung, Endobronchial, Mediastinal or Pleural Metastases | Experimental | Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy Receives: Procedure: Chemoembolization; Drug: Mitomycin C; Drug: Lipiodol; Drug: Embospheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant toxicity will be evaluated according to CTCAE v5.0
Safety will be evaluated by participant toxicity according to CTCAE v5.0
Measured: Up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start13 Dec 2019
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung MetastasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Solomon, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200417
- Sponsor's protocol ID
- 19-371
- Status last verified
- Apr 2022
- First submitted
- 13 Dec 2019
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Transarterial Chemoembolization of Lung Metastases
- ClinicalTrials.gov ID
- NCT04200417
- Acronym / sponsor ID
- 19-371
- Keywords
- Unresectable Lung Cancer, Unresectable Endobronchial Mestastases, Unresectable Pleural Metastases, Unresectable Mediastinal Metastases, Lung Chemoembolization, 19-371, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 16 Dec 2019 (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 study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung, Endobronchial, Mediastinal or Pleural Metastases | Experimental | Procedure: Chemoembolization, Drug: Mitomycin C, Drug: Lipiodol, Drug: EmbospheresParticipants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or SBRT.
- At least 18 years old.
- ECOG performance status 0 or 1
Key exclusion criteria (22 listed)
- Primary lung cancer
- >50% of a lung is replaced with tumor
- Oxygen saturation <92% on room air
- FEV1 <60%
- Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, MRI, or direct pressure measurement)
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 |
|---|---|---|
| ChemoembolizationChemoembolization will be performed via the artery (bronchial, non-bronchial systemic, or pulmonary) that shows the greatest tumor enhancement on angiography. Chemoembolization will be performed using a lipiodol / mitomycin emulsion, followed by spherical particles. | Procedure or surgery | Lung, Endobronchial, Mediastinal or Pleural Metastases |
| Mitomycin CMitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure. | Drug | Lung, Endobronchial, Mediastinal or Pleural Metastases |
| LipiodolMitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure. | Drug | Lung, Endobronchial, Mediastinal or Pleural Metastases |
| EmbospheresEmbospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors. | Drug | Lung, Endobronchial, Mediastinal or Pleural Metastases |
Primary outcome
Participant toxicity will be evaluated according to CTCAE v5.0
Time frame: Up to 12 months post treatment
Safety will be evaluated by participant toxicity according to CTCAE v5.0
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 16 May 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Stephen Solomon, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chemoembolization, Mitomycin C and Lipiodol in people with Lung Metastases and Endobronchial Metastases, run by Memorial Sloan Kettering Cancer Center at 4 sites 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 22 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Participant toxicity will be evaluated according to CTCAE v5.0 (time frame: Up to 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.