Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells

• Status: Active, not recruiting
• Trial end date: 2022-04-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Bumetanide; Diuretics

Criteria

Inclusion Criteria:

• Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1). Regional lymphadenopathy will be allowed.

• Any virus status accepted (e.g. Hepatitis C etc.)

• Any prior liver treatment

• Patients within unresectable HCC

• At least 18 years old

• ECOG performance status 0 or 1

• Radiographically measurable disease per mRECIST 1.1

• Meets standard of care to undergo embolization

Exclusion Criteria:

• Women who are pregnant or lactating

• Documented hypersensitivity to bumetanide or sulfonamides

• Patients with resectable HCC

• High risk for post-embolization hepatic failure:

°Child's C cirrhosis

°> 80% liver involvement by tumor

• Contraindication to angiography/embolization including:

• Patients cannot receive contrast:

• Severe allergic reaction to contrast despite premedication

• Poor renal function not on dialysis

• Other, based on judgment of the investigator

• ECOG score 2

• Main portal vein tumor thrombus

• BCLC D = patients with distant metastasis