This phase I trial studies the side effects of transarterial chemoembolization in treating patients with tumors that has spread to the lungs (lung metastases). Lung chemoembolization works by delivering chemotherapy directly into the artery that supplies oxygen to lung tumors. At the same time, the artery is plugged up (embolized). 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04200417.
PRIMARY OBJECTIVES:
I. Safety of lung chemoembolization.
II. Technical success rate.
SECONDARY OBJECTIVES:
I. Objective response rate (partial or complete response) of treated lesions at 4-6 weeks, among patients who had a technically successful treatment.
II. Percentage of lung metastases supplied by bronchial artery, non-bronchial systemic artery, and pulmonary artery, based on catheter angiography.
III. Agreement between predicted blood supply (bronchial versus pulmonary artery) to lung metastases, based on non-invasive imaging (triphasic lung computed tomography [CT]), and actual blood supply, as determined by catheter angiography.
IV. Fraction of prescribed dose of mitomycin that could be delivered (total mitomycin dose delivered / total prescribed dose).
V. Pharmacokinetics of intra-arterial mitomycin, including: peak concentration (Cmax), volume of distribution, area under curve (AUC), and termination half-life (t 1/2).
VI. Lipiodol retention in tumors, based on Hounsfield units on non-contrast CT obtained immediately and 4-6 weeks post-procedure.
OUTLINE:
Patients receive mitomycin intra-arterially (IA) and lipiodol IA while undergoing transarterial chemoembolization. If the embolization endpoint is not reached, patients may also receive tris-acryl gelatin microspheres IA.
After completion of study treatment, patients are followed up at 1-2 and 4-6 weeks.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorStephen Barnett Solomon
