Lung Non-Small Cell Carcinoma, Mediastinal Neoplasm, Pleural Neoplasm, Lung Metastases From Any Primary, Endobronchial Metastases, Colon Cancer, Sarcoma
Conditions
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'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.
Interventions
PROCEDUREComputed Tomography
Undergo CT
DRUGEthiodized Oil
Given IA
DRUGMitomycin
Given IA
PROCEDURETransarterial Chemoembolization
Undergo TACE
DEVICETris-acryl Gelatin Microspheres
Given IA
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local progression free survival | 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 | Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method. |
| Incidence of adverse events | Up to 3 months after the last chemoembolization procedure | Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (best response) | Within 3 months of treatment | Evaluated on a per-treatment basis, using RECIST version 1.1 criteria. |
| Overall survival | Up to 9 months | Will be estimated using the Kaplan-Meier method. |
| Progression-free survival | Up to 9 months | Will be estimated using the Kaplan-Meier method. |
| Bronchial versus pulmonary artery blood supply | Up to 9 months | Percentage of treatments where target tumors were supplied by bronchial artery, non-bronchial systemic artery, or pulmonary artery, based on catheter angiography. Confidence intervals of proportions will be estimated using the equal-tailed Jeffreys prior interval. |
| Lipiodol retention in treated tumors | 4-6 weeks post-procedure | Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test. |
| Growth of TACE targeted lesions versus non-TACE targeted lesions | 4-6 weeks post-procedure | Percentage change in size (largest diameter) of the largest treated, compared to the largest untreated tumor will be evaluated using the Wilcoxon signed-rank test. |
Countries
United States
Contacts
CONTACTFranz Edward Boas, MD
PRINCIPAL_INVESTIGATORFranz E Boas, MD
City of Hope Medical Center
Outcome results
None listed