Clinical trial NCT05672108: Phase II Trial of Lung Chemoemobolization
Official title: Phase II Trial of Lung Chemoemobolization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Non-Small Cell Carcinoma
Mediastinal Neoplasm
Pleural Neoplasm
Lung Metastases From Any Primary
Endobronchial Metastases
Colon Cancer
Sarcoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-05
Enrollment: 30
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 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\&#39;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.

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 \&gt; 2
* Oxygen saturation \&lt; 92% on room air
* Forced expiratory volume in 1 second (FEV1) \&lt; 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 \&lt; 1 cm)
* Life expectancy \&lt; 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 \[eGFR\] \&lt; 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 \&lt; 50,000 (after transfusion, if needed)
* International normalized ratio (INR) \&gt; 2 (after transfusion, if needed)
* Hemoglobin \&lt; 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

Primary outcomes:
measure: Local progression free survival
timeFrame: 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
measure: Incidence of adverse events
timeFrame: Up to 3 months after the last chemoembolization procedure
Secondary outcomes:
measure: Objective response rate (best response)
timeFrame: Within 3 months of treatment
measure: Overall survival
timeFrame: Up to 9 months
measure: Progression-free survival
timeFrame: Up to 9 months
measure: Bronchial versus pulmonary artery blood supply
timeFrame: Up to 9 months
measure: Lipiodol retention in treated tumors
timeFrame: 4-6 weeks post-procedure
measure: Growth of TACE targeted lesions versus non-TACE targeted lesions
timeFrame: 4-6 weeks post-procedure
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: City of Hope Medical Center
name: Franz E Boas, MD
role: PRINCIPAL_INVESTIGATOR
References: