Phase II Trial of Lung Chemoemobolization

City of Hope

Status and phase: Enrolling; Phase 2

Conditions: Lung Metastases From Any Primary; Sarcoma; Colon Cancer; Pleural Neoplasm; Endobronchial Metastases; Lung Non-Small Cell Carcinoma; Mediastinal Neoplasm

Treatments: Drug: Mitomycin; Procedure: Computed Tomography; Procedure: Transarterial Chemoembolization; Device: Tris-acryl Gelatin Microspheres; Drug: Ethiodized Oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05672108

NCI-2022-10436 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

22067 (Other Identifier)

Details and patient eligibility

About

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. 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. TACE can be effective at controlling or stopping the growth of lung tumors.

Full description

PRIMARY OBJECTIVE:

I. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.

OUTLINE:

Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Lung cancer or lung metastases, 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lung chemoembolization

Experimental group

Description:

Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.

Treatment:

Drug: Ethiodized Oil

Device: Tris-acryl Gelatin Microspheres

Procedure: Transarterial Chemoembolization

Procedure: Computed Tomography

Drug: Mitomycin