Chemoembolization for Lung Tumors
Phase I Study of Transarterial Chemoembolization of Lung Metastases
1 other identifier
interventional
10
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2019
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2019
CompletedStudy Start
First participant enrolled
December 13, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2022
CompletedMay 16, 2025
April 1, 2022
2.4 years
December 13, 2019
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant toxicity will be evaluated according to CTCAE v5.0
Safety will be evaluated by participant toxicity according to CTCAE v5.0
Up to 12 months post treatment
Study Arms (1)
Lung, Endobronchial, Mediastinal or Pleural Metastases
EXPERIMENTALParticipants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy
Interventions
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 (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Solomon, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2019
First Posted
December 16, 2019
Study Start
December 13, 2019
Primary Completion
April 19, 2022
Study Completion
April 19, 2022
Last Updated
May 16, 2025
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
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.