Overview

Chemoembolization for Lung Tumors

Status:
Active, not recruiting
Trial end date:
2022-12-13
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
Ethiodized Oil
Mitomycin
Mitomycins
Criteria
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