Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2023-05-12
2026-10-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Computed Tomography
Undergo CT
Ethiodized Oil
Given IA
Mitomycin
Given IA
Transarterial Chemoembolization
Undergo TACE
Tris-acryl Gelatin Microspheres
Given IA
Interventions
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Computed Tomography
Undergo CT
Ethiodized Oil
Given IA
Mitomycin
Given IA
Transarterial Chemoembolization
Undergo TACE
Tris-acryl Gelatin Microspheres
Given IA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lung-dominant disease (majority of active tumor volume is in the chest)
* At least 18 years old
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Franz E Boas, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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NCI-2022-10436
Identifier Type: REGISTRY
Identifier Source: secondary_id
22067
Identifier Type: OTHER
Identifier Source: secondary_id
22067
Identifier Type: -
Identifier Source: org_study_id
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