Trial Title:
Transarterial Chemoembolization for the Treatment of Lung Cancer and Lung Metastases
NCT ID:
NCT05672108
Condition:
Lung Non-Small Cell Carcinoma
Mediastinal Neoplasm
Pleural Neoplasm
Lung Metastases From Any Primary
Endobronchial Metastases
Colon Cancer
Sarcoma
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Neoplasms
Mediastinal Neoplasms
Mitomycins
Mitomycin
Ethiodized Oil
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Lung chemoembolization
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Ethiodized Oil
Description:
Given IA
Arm group label:
Lung chemoembolization
Other name:
Ethiodol
Other name:
Iodized Oil
Other name:
Lipiodol
Intervention type:
Drug
Intervention name:
Mitomycin
Description:
Given IA
Arm group label:
Lung chemoembolization
Other name:
Ametycine
Other name:
Jelmyto
Other name:
MITO
Other name:
Mito-C
Other name:
Mito-Medac
Other name:
Mitocin
Other name:
Mitocin-C
Other name:
Mitolem
Other name:
Mitomycin C
Other name:
Mitomycin-C
Other name:
Mitomycin-X
Other name:
Mitomycine C
Other name:
Mitosol
Other name:
Mitozytrex
Other name:
Mutamycin
Other name:
Mutamycine
Other name:
NCI-C04706
Intervention type:
Procedure
Intervention name:
Transarterial Chemoembolization
Description:
Undergo TACE
Arm group label:
Lung chemoembolization
Other name:
TACE
Intervention type:
Device
Intervention name:
Tris-acryl Gelatin Microspheres
Description:
Given IA
Arm group label:
Lung chemoembolization
Other name:
Embospheres
Other name:
TAGM
Other name:
Trisacryl Gelatin Microspheres
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Franz E. Boas
Phone:
626-218-8708
Email:
fboas@coh.org
Investigator:
Last name:
Franz E. Boas
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephen B. Solomon, MD
Phone:
212-639-5012
Email:
solomons@mskcc.org
Investigator:
Last name:
Stephen B. Solomon, MD
Email:
Principal Investigator
Start date:
May 12, 2023
Completion date:
October 27, 2024
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672108
