Phase II Trial of Lung Chemoemobolization

NCT05672108 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 3 other identifiers: 22067P30CA033572NCI-2022-10436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Objective response rate (best response)

  Within 3 months of treatment

• Overall survival

  Up to 9 months

• Progression-free survival

  Up to 9 months

• Bronchial versus pulmonary artery blood supply

  Up to 9 months

• Lipiodol retention in treated tumors

  4-6 weeks post-procedure

Study Arms (1)

Lung chemoembolization

EXPERIMENTAL

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

Interventions

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Lung chemoembolization

Ethiodized Oil DRUG

Given IA

Also known as: Ethiodol, Iodized Oil, Lipiodol

Lung chemoembolization

Mitomycin DRUG

Given IA

Also known as: Ametycine, Jelmyto, MITO, Mito-C, Mito-Medac, Mitocin, Mitocin-C, Mitolem, Mitomycin C, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706

Lung chemoembolization

Transarterial Chemoembolization PROCEDURE

Undergo TACE

Also known as: TACE

Lung chemoembolization

Tris-acryl Gelatin Microspheres DEVICE

Given IA

Also known as: Embospheres, TAGM, Trisacryl Gelatin Microspheres

Lung chemoembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• Boas FE, Salgia R, Waddington T, Massarelli E, Park JJ, Kessler J, Frankel P, Alexander ES, Solomon SB. Phase II Trial of Lung Chemoembolization. J Vasc Interv Radiol. 2023 Dec;34(12):2090-2092. doi: 10.1016/j.jvir.2023.08.006. Epub 2023 Aug 21. No abstract available.

  PMID: 37611799 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Mediastinal Neoplasms; Pleural Neoplasms; Colonic Neoplasms; Sarcoma

Interventions

Ethiodized Oil; Iodized Oil; Mitomycin; Mitozytrex

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mediastinal Diseases; Thoracic Diseases; Pleural Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Franz E Boas, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franz Edward Boas, MD

CONTACT

626-218-8708; fboas@coh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: May 12, 2023
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (2)