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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03107416
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Unresectable Hepatocellular Carcinoma Procedure: Hepatic artery embolization (HAE) Drug: Bumetanide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bumetanide

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107416


Contacts
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Contact: Hooman Yarmohammadi, MD 212-639-2234 yarmohah@mskcc.org
Contact: Joseph Erinjeri, MD, PhD 212-639-3363

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent and follow-up only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Hooman Yarmohammadi, MD    212-639-2234      
Memorial Sloan Kettering Monmouth (Consent and follow-up only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Hooman Yarmohammadi, MD    212-639-2234      
Memorial Sloan Kettering Bergen (Consent and follow-up only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Hooman Yarmohammadi, MD    212-639-2234      
United States, New York
Memorial Sloan Kettering Westchester (Consent and follow-up only) Recruiting
Harrison, New York, United States, 10604
Contact: Hooman Yarmohammadi, MD    212-639-2234      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Hooman Yarmohammadi, MD    212-639-2234      
Contact: Joseph Erinjeri, MD, PhD    212-639-3363      
Principal Investigator: Hooman Yarmohammadi, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Hooman Yarmohammadi, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03107416    
Other Study ID Numbers: 17-141
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Bumetanide
Diuretic
Transarterial Embolization (TAE)
17-141
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bumetanide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action