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

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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

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE April 5, 2017
Estimated Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Maximum tolerated dose (MTD) (phase I) [ Time Frame: 1 year ]
    Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.04 mg/kg (level 2) and 0.1 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) [ 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
Official Title  ICMJE Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unresectable Hepatocellular Carcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Hepatic artery embolization (HAE)
  • Drug: Bumetanide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
30
Estimated Study Completion Date  ICMJE April 5, 2021
Estimated Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hooman Yarmohammadi, MD 212-639-2234 yarmohah@mskcc.org
Contact: Joseph Erinjeri, MD, PhD 212-639-3363
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03107416
Other Study ID Numbers  ICMJE 17-141
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hooman Yarmohammadi, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP