Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT03107416
This study evaluates the safety of Bumetanide at varying doses in patients with unresectable HCC undergoing hepatic artery embolization (HAE). Eligible participants are adults with HCC per EASL criteria, any virus status, prior liver treatment, ECOG 0-1, and measurable disease. Bumetanide is administered intra-arterially during HAE in escalating doses across cohorts.
Patient Parameters
| Parameter | Options |
|---|
Program 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.
Eligibility Criteria
Inclusion Criteria
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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
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Patients within unresectable HCC
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At least 18 years old
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ECOG performance status 0 or 1
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Radiographically measurable disease per mRECIST 1.1
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Meets standard of care to undergo embolization
Exclusion Criteria
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Women who are pregnant or lactating
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Documented hypersensitivity to bumetanide or sulfonamides
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Patients with resectable HCC
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High risk for post-embolization hepatic failure:
°Child's C cirrhosis
°> 80% liver involvement by tumor
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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
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ECOG score 2
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Main portal vein tumor thrombus
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BCLC D = patients with distant metastasis
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Consent and follow-up only) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Consent and follow-up only) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Westchester (Consent and follow-up only) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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