Chemoembolization for Lung Tumors

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Mediastinal Metastases; Pleural Metastases; Endobronchial Metastases; Lung Metastases

Treatments: Drug: Lipiodol; Drug: Mitomycin C; Procedure: Chemoembolization; Drug: Embospheres

Study type: Interventional

Funder types: Other

Identifiers

NCT04200417

19-371

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Lung, Endobronchial, Mediastinal or Pleural Metastases

Experimental group

Description:

Participants will have unresectable and unablatable lung, endobronchial, mediastinal, or pleural metastases (from any primary) that are not responding to chemotherapy

Treatment:

Drug: Embospheres

Drug: Mitomycin C

Procedure: Chemoembolization

Drug: Lipiodol