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NCT05672108
Transarterial Chemoembolization for the Treatment of Lung Cancer
Conditions: Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm, Pleural Neoplasm
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 30
Sponsor: City of Hope Medical Center
Location: United States
Summary
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.
Eligibility 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 therapyLung-dominant disease (majority of active tumor volume is in the chest)At least 18 years oldExclusion Criteria:Eastern Cooperative Oncology Group (ECOG) performance status > 2Oxygen saturation < 92% on room airForced 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 monthsPulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [MRI], or direct pressure measurement)Recent pulmonary embolism (within 3 months)Pulmonary arteriovenous malformationActive 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 pregnantBreast feedingAltered mental status that would interfere with consent or follow-upPlatelets < 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 mitomycinAllergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedicationAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety
Source: ClinicalTrials.gov (NCT05672108). StuddyBuddy aggregates publicly available trial information.