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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Unresectable Hepatocellular Carcinoma

Treatments: Drug: Bumetanide; Procedure: Hepatic artery embolization (HAE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03107416

17-141

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Bumetanide

Experimental group

Description:

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.

Treatment:

Procedure: Hepatic artery embolization (HAE)

Drug: Bumetanide