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

NCT03107416 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 17-141
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Bumetanide; Diuretic; Transarterial Embolization (TAE); 17-141

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Bumetanide

EXPERIMENTAL

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.

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

Interventions

Hepatic artery embolization (HAE) PROCEDURE

The intervention being studied is HAE for the treatment of HCC in combination with Bumetanide. HAE is a standard of care procedure.

Bumetanide

Bumetanide DRUG

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.

Bumetanide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent and follow-up only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and follow-up only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Westchester (Consent and follow-up only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Bumetanide

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Hooman Yarmohammadi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: April 5, 2017
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (5)