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

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03107416
• Other study ID #: 17-141
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 5, 2017
• Est. completion date: April 5, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 5, 2025
• Est. primary completion date: April 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Procedure:
• Hepatic artery embolization (HAE)
The intervention being studied is HAE for the treatment of HCC in combination with Bumetanide. HAE is a standard of care procedure.

Drug:
• Bumetanide
Intra-arterial (IA) injection of 0.01mg/kg of Bumetanide in the first cohort, 0.02 mg/kg in the second cohort and 0.04 mg/kg of IA Bumetanide in the final cohort patients during standard HAE until stasis is evident.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Westchester (Consent and follow-up only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent and follow-up only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent and follow-up only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) (phase I)	Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level.	1 year
Primary	estimate the local tumor progression (LTP) rates (phase II)	After the last first stage patient has three months followup, 6-month LTP will be estimated using Kaplan-Meier methods. If the one-sided 90% lower confidence bound is less than 40% the study will stop. Otherwise 12 more patients will be enrolled for a total of 30. At the end of the study 12-month LTP will be estimated using competing risk (cumulative incidence) methods.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center