Clinical trial NCT04200417: Chemoembolization for Lung Tumors
Official title: Phase I Study of Transarterial Chemoembolization of Lung Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Metastases
Endobronchial Metastases
Pleural Metastases
Mediastinal Metastases
Keywords: Unresectable Lung Cancer
Unresectable Endobronchial Mestastases
Unresectable Pleural Metastases
Unresectable Mediastinal Metastases
Lung Chemoembolization
19-371
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.


Eligibility criteria: Inclusion Criteria:

* Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or SBRT.
* At least 18 years old.
* ECOG performance status 0 or 1

Exclusion Criteria:

* Primary lung cancer
* \>50% of a lung is replaced with tumor
* Oxygen saturation \<92% on room air
* FEV1 \<60%
* Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, 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 (dyspnea, volume overload)
* Left bundle branch block (contraindication to pulmonary angiography)
* Renal failure (eGFR \<30 mL/min/1.73m\^2)
* Pregnancy
* Breastfeeding
* Altered mental status that would interfere with consent or follow-up
* Platelets \< 100,000 (after transfusion, if needed)
* INR\>2 (after transfusion, if needed)
* Hemoglobin \<7 (after transfusion, if needed)
* Hyperthyroidism (contraindication to lipiodol)
* Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
* Allergy to lipiodol or mitomycin
* Allergy to iodinated contrast that can not be treated with steroid / diphenhydramine premedication
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

Primary outcomes:
measure: Participant toxicity will be evaluated according to CTCAE v5.0
timeFrame: Up to 12 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Stephen Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: