Chemoembolization for Lung Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study of Transarterial Chemoembolization of Lung Metastases

Conditions
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Lung Metastases, Endobronchial Metastases, Pleural Metastases, Mediastinal Metastases

Intervention / Treatment
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* Procedure: Chemoembolization
* Drug: Mitomycin C
* Drug: Lipiodol
* Drug: Embospheres


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung, Endobronchial, Mediastinal or Pleural Metastases<br>Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy | Procedure: Chemoembolization<br>* 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.<br>Drug: Mitomycin C<br>* Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.<br>Drug: Lipiodol<br>* Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.<br>Drug: Embospheres<br>* Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable Lung Cancer, Unresectable Endobronchial Mestastases, Unresectable Pleural Metastases, Unresectable Mediastinal Metastases, Lung Chemoembolization, 19-371, Memorial Sloan Kettering Cancer Center