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

Status:	Recruiting
Conditions:	Liver Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/6/2019
Start Date:	April 5, 2017
End Date:	April 5, 2020
Contact:	Hooman Yarmohammadi, MD
Email:	yarmohah@mskcc.org
Phone:	212-639-2234

Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma

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.

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

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000