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Transarterial Chemoembolization for the Treatment of Lung Cancer

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ClinicalTrials.gov Identifier: NCT05672108
Recruitment Status : Not yet recruiting
First Posted : January 5, 2023
Last Update Posted : January 5, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lung Non-Small Cell Carcinoma Mediastinal Neoplasm Pleural Neoplasm Procedure: Angiography Procedure: Computed Tomography Drug: Ethiodized Oil Drug: Mitomycin Procedure: Transarterial Chemoembolization Drug: Tris-acryl Gelatin Microspheres Phase 2

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Lung Chemoembolization
Estimated Study Start Date : May 24, 2023
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (TACE, mitomycin, ethiodized oil, embospheres)
Patients receive lipiodol IA, mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and CT at baseline and follow up.
 Procedure: Angiography
Undergo angiography

Procedure: Computed Tomography
Undergo CT
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Ethiodized Oil
Given IA
Other Names:
  • Ethiodol
  • Iodized Oil
  • Lipiodol

Drug: Mitomycin
Given IA
Other Names:
  • 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

Procedure: Transarterial Chemoembolization
Undergo TACE
Other Name: TACE

Drug: Tris-acryl Gelatin Microspheres
Given IA
Other Names:
  • Embospheres
  • TAGM
  • Trisacryl Gelatin Microspheres


Outcome Measures
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Primary Outcome Measures :
  1. Local progression free survival [ Time Frame: 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 ]
    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.

  2. Incidence of adverse events [ Time Frame: Up to 3 months after the last chemoembolization procedure ]
    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.

  3. Change in oxygen saturation [ Time Frame: Pre and post procedure, assessed up to 9 months ]
    Will be evaluated using the Wilcoxon signed-rank test.

  4. Change in forced vital capacity [ Time Frame: Pre and post procedure, assessed up to 9 months ]
    Will be evaluated using the Wilcoxon signed-rank test.

  5. Change in forced expiratory volume in 1 second [ Time Frame: Pre and post procedure, assessed up to 9 months ]
    Will be evaluated using the Wilcoxon signed-rank test.


Secondary Outcome Measures :
  1. Objective response rate (best response) [ Time Frame: Within 3 months of treatment ]
    Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.

  2. Overall survival [ Time Frame: Up to 9 months ]
    Will be estimated using the Kaplan-Meier method.

  3. Progression-free survival [ Time Frame: Up to 9 months ]
    Will be estimated using the Kaplan-Meier method.

  4. Bronchial versus pulmonary artery blood supply [ Time Frame: Up to 9 months ]
    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.

  5. Lipiodol retention in treated tumors [ Time Frame: 4-6 weeks post-procedure ]
    Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.

  6. Growth of TACE targeted lesions versus non-TACE targeted lesions [ Time Frame: 4-6 weeks post-procedure ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05672108


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Contact: Franz E. Boas    626-218-8708    fboas@coh.org   
Principal Investigator: Franz E. Boas         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Franz E Boas City of Hope Medical Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT05672108    
Other Study ID Numbers: 22067
NCI-2022-10436 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
22067 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2023    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Neoplasms
Mediastinal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Pleural Diseases
Mediastinal Diseases
Thoracic Diseases
Mitomycins
Mitomycin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors