Lung Metastases, Endobronchial Metastases, Pleural Metastases, Mediastinal Metastases
Conditions
Keywords
Unresectable Lung Cancer, Unresectable Endobronchial Mestastases, Unresectable Pleural Metastases, Unresectable Mediastinal Metastases, Lung Chemoembolization, 19-371, Memorial Sloan Kettering Cancer Center
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.
Interventions
PROCEDUREChemoembolization
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.
DRUGMitomycin C
Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
DRUGLipiodol
Mitomycin (5mg/m\^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
DRUGEmbospheres
Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant toxicity will be evaluated according to CTCAE v5.0 | Up to 12 months post treatment | Safety will be evaluated by participant toxicity according to CTCAE v5.0 |
Countries
United States
Outcome results
None listed