This phase I/II trial studies the best dose of bumetanide when given together with hepatic artery embolization and to see how well they work in treating patients with liver cancer that cannot be removed by surgery. Bumetanide may slow down the part of tumor metabolism. Hepatic artery embolization blocks blood vessels that supply tumors in the liver with small particles and cut off the oxygen supply. Giving bumetanide before hepatic artery embolization may kill more tumor compared to the normal practice.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03107416.
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of intra-arterial injection of bumetanide. (Phase I)
II. Local tumor progression (LTP). (Phase II)
SECONDARY OBJECTIVES:
I. Time to progression (TTP), defined as the time elapsed from start of treatment until progression of disease (POD) by modified Response Evaluation Criteria in Solid Tumors (mRECIST). (Phase II)
II. Overall survival. (Phase II)
III. Overall response to treatment (RTT) according to mRECIST. (Phase II)
IV. Toxicities and adverse events. (Phase II)
V. Changes in alpha-fetoprotein. (Phase II)
VI. Hospital stay. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of bumetanide followed by a phase II study.
Patients receive bumetanide via intra-arterial injection and undergo hepatic artery embolization (HAE) as per standard of care until stasis is evident. Patients requiring a second embolization to complete treatment may undergo embolization within 4-6 weeks of the initial embolization session.
After completion of study treatment, patients are followed up at 7-14 days, 5 weeks, and 3, 6, 12, and 24 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorHooman Yarmohammadi
