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Diuretic + Arterial Embolization for Liver Cancer

Phase 1 & 2

Waitlist Available

Led By Hooman Yarmohammadi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets standard of care to undergo embolization

Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1) with regional lymphadenopathy allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing the safety of a medication, Bumetanide, to see if it has any effect on people who regularly undergo tumor TAE (a medical procedure).

Who is the study for?

This trial is for adults with inoperable liver cancer, regardless of viral status. They must have a good performance status (able to carry out daily activities), measurable disease by specific criteria, and be eligible for embolization treatment. People can't join if they're pregnant or breastfeeding, allergic to bumetanide/sulfonamides, have resectable cancer, poor kidney function not on dialysis, certain blood vessel blockages or advanced cirrhosis.Check my eligibility

What is being tested?

The study tests the safety of different doses of Bumetanide when delivered directly into the liver artery followed by plugging up the artery—a procedure known as Hepatic Artery Embolization—to treat liver cancer. The goal is to see how this approach affects patients who are already getting tumor embolization as part of their standard care.See study design

What are the potential side effects?

Bumetanide may cause dehydration due to increased urination; it could also lead to electrolyte imbalances like low potassium levels. There might be local reactions at the infusion site or more general side effects such as dizziness or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a procedure to block blood flow to cancer cells.

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I have been diagnosed with liver cancer following EASL guidelines.

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I have had treatment for my liver before.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My liver cancer cannot be removed with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) (phase I)

estimate the local tumor progression (LTP) rates (phase II)

Side effects data

From 2019 Phase 2 trial • 34 Patients • NCT03923933

69%

Creatinine Increase

25%

hyperuricemia

13%

Hyponatremia

13%

hypokalemia

Major adverse cardiovascular events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Treatment Grup

Trial Design

1Treatment groups

Experimental Treatment

Group I: BumetanideExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Bumetanide

2010

Completed Phase 2

~260

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,590 Total Patients Enrolled

21 Trials studying Liver Cancer

7,846 Patients Enrolled for Liver Cancer

Hooman Yarmohammadi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Hepatic Artery Embolization (HAE) Clinical Trial Eligibility Overview. Trial Name: NCT03107416 — Phase 1 & 2

Liver Cancer Research Study Groups: Bumetanide

Liver Cancer Clinical Trial 2023: Hepatic Artery Embolization (HAE) Highlights & Side Effects. Trial Name: NCT03107416 — Phase 1 & 2

Hepatic Artery Embolization (HAE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03107416 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Bumetanide been studied in any other contexts?

"Bumetanide's clinical trials were initiated at Yale University in 2015. 10 completed studies have been conducted, and 5 are still ongoing. Several of the active trials are located within New york City."

Answered by AI

Are there any open recruitment slots in this research project?

"The clinical trial that is the focus of this inquiry, according to information hosted on clinicaltrials.gov, has ceased recruitment activity since its last update in November 2022; however there are still 2602 other trials actively recruiting participants at this time."

Answered by AI

To what conditions is Bumetanide typically applied as a remedy?

"Bumetanide is a highly effective treatment for nephritic conditions, hepatic dysfunction, and edema."

Answered by AI

How many facilities are overseeing this trial?

"As of now, this clinical trial is running out of 5 sites; namely New york, Basking Ridge and Middletown as well as two more. To lessen the burden of travelling, it's advisable to select the closest medical centre if you choose to join in."

Answered by AI

What is the present size of this research endeavor?

"This clinical trial is no longer actively seeking participants. As per the information posted on 4/5/2017 and updated 11/22/2022, it is not currently open for recruitment. However, there are presently 2597 trials recruiting patients with carcinoma and 5 studies looking to enroll individuals in a Bumetanide-based program."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03107416.

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