Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
- Conditions
- Unresectable Hepatocellular Carcinoma
- Interventions
- Procedure: Hepatic artery embolization (HAE)
- Registration Number
- NCT03107416
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bumetanide 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. Bumetanide Hepatic artery embolization (HAE) 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.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) (phase I) 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Memorial Sloan Kettering Westchester (Consent and follow-up only)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
🇺🇸Basking Ridge, New Jersey, 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, United States