Transarterial Chemoembolization for the Treatment of Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial evaluates how well transarterial chemoembolization (TACE) works in treating patients with non-small cell lung cancer. TACE involves the injection of a blocking agent (tris-acryl gelatin microspheres [embospheres]) and a chemotherapy agent (mitomycin) directly into the artery that supplies oxygen to lung tumors. Mitomycin works by inhibiting deoxyribonucleic acid synthesis. At the same time, the artery is blocked (embolized) with a blocking agent called tris-acryl gelatin microspheres (embospheres). This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. An imaging agent called ethiodized oil (lipiodol) is also used during the procedure for help visualizing the tumor. TACE with mitomycin, lipiodol, and embospheres may be effective at controlling or stopping the growth of lung tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ethiodized Oil; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Non-small cell lung cancer (any stage), with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy

• Lung-dominant disease (majority of active tumor volume is in the chest)

• At least 18 years old

Exclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status > 2

• Oxygen saturation < 92% on room air

• Forced expiratory volume in 1 second (FEV1) < 60%

• No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all < 1 cm)

• Life expectancy < 6 months

• Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [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 (American College of Cardiology [ACC]/American Heart Association [AHA] stage C or D)

• Left bundle branch block (contraindication to pulmonary angiography)

• Renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2)

• Pregnancy or intent to become pregnant

• Breast feeding

• Altered mental status that would interfere with consent or follow-up

• Platelets < 50,000 (after transfusion, if needed)

• International normalized ratio (INR) > 2 (after transfusion, if needed)

• Hemoglobin < 7 (after transfusion, if needed)

• Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)

• Planned radioactive iodine imaging or therapy (contraindication to lipiodol)

• Allergy to lipiodol or mitomycin

• Allergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedication

• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety