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

Overview

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.

Full Title of Study: “Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 5, 2024

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Bumetanide
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum tolerated dose (MTD) (phase I)
    • Time Frame: 1 year
    • 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.
  • estimate the local tumor progression (LTP) rates (phase II)
    • Time Frame: 1 year
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hooman Yarmohammadi, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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