Transarterial Chemoembolization for the Treatment of Lung Cancer

Phase II Trial of Lung Chemoembolization

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer. 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.

Study Overview

• Status: Recruiting
• Conditions: Lung Non-Small Cell Carcinoma; Mediastinal Neoplasm; Pleural Neoplasm
• Intervention / Treatment: Procedure: Computed Tomography; Procedure: Transarterial Chemoembolization; Drug: Ethiodized Oil; Drug: Mitomycin; Device: Tris-acryl Gelatin Microspheres

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Franz E. Boas; Phone Number: 626-218-8708; Email: fboas@coh.org
      • Principal Investigator: Franz E. Boas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lung chemoembolization; 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.

Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Transarterial Chemoembolization; Undergo TACE; Other Names: TACE; Drug: Ethiodized Oil; Given IA; Other Names: Ethiodol; Lipiodol; Iodized Oil; Drug: Mitomycin; Given IA; Other Names: Mutamycin; Ametycine; Jelmyto; MITO; Mito-C; Mito-Medac; Mitocin; Mitocin-C; Mitolem; Mitomycin C; Mitomycin-C; Mitomycin-X; Mitomycine C; Mitosol; Mitozytrex; Mutamycine; NCI-C04706; Device: Tris-acryl Gelatin Microspheres; Given IA; Other Names: Embospheres; TAGM; Trisacryl Gelatin Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local progression free survival	Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method.	Time from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months
Incidence of adverse events	Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability.	Up to 3 months after the last chemoembolization procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (best response)	Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.	Within 3 months of treatment
Overall survival	Will be estimated using the Kaplan-Meier method.	Up to 9 months
Progression-free survival	Will be estimated using the Kaplan-Meier method.	Up to 9 months
Bronchial versus pulmonary artery blood supply	Percentage of treatments where target tumors were supplied by bronchial artery, non-bronchial systemic artery, or pulmonary artery, based on catheter angiography. Confidence intervals of proportions will be estimated using the equal-tailed Jeffreys prior interval.	Up to 9 months
Lipiodol retention in treated tumors	Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.	4-6 weeks post-procedure
Growth of TACE targeted lesions versus non-TACE targeted lesions	Percentage change in size (largest diameter) of the largest treated, compared to the largest untreated tumor will be evaluated using the Wilcoxon signed-rank test.	4-6 weeks post-procedure

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Franz E Boas, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Mediastinal Diseases; Thoracic Diseases; Neoplasms; Carcinoma, Non-Small-Cell Lung; Mediastinal Neoplasms; Pleural Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin; Ethiodized Oil
• Other Study ID Numbers: 22067 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-10436 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes