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Biomarker Testing in Studying APAP-CYS Concentrations in Primary or Secondary Liver Cancer Patients with Non-acetaminophen Induced Liver Injury

Trial Status: Active

This phase IV trial studies APAP-CYS concentrations in primary or secondary liver cancer patients with non-acetaminophen induced liver injury after taking therapeutic doses of acetaminophen. This research may help doctors in the future better understand protein adduct concentrations in patient’s blood.

Inclusion Criteria

  • Subjects who are able to provide written, informed consent
  • Subjects with liver metastasis of a non-hepatic tumor
  • Subjects with hepatocellular carcinoma and child class A cirrhosis
  • Subjects undergoing portal vein or bland embolization for the treatment of primary or metastatic hepatic tumor
  • Subjects undergoing drug-eluting beads (DEB) transarterial chemoembolization for the treatment of metastatic or primary hepatic tumor
  • Subjects undergoing radioembolization for the treatment of primary or metastatic hepatic tumor
  • Subjects undergoing any form of ischemic embolization for the treatment of primary or metastatic hepatic tumor
  • Subjects who are willing to have their blood drawn at least 12 times for study purposes; additional blood draws may be necessary for safety purposes
  • Subjects who agree to stay for ~18-21 hours after being discharged from the Department of Radiology for research purposes
  • Subjects who agree to refrain from using acetaminophen, other than the study drug, during the dosing phase through a minimum of 5 days post procedure * Subjects who develop laboratory abnormalities will be instructed to avoid using acetaminophen until resolution or stabilization of laboratory values
  • Subjects who agree to consume less than 3 alcoholic drinks per day while taking study drug (acetaminophen group only)
  • Subjects who are willing to complete a study diary for 3 days prior to and the day of the procedure
  • Subjects who will be in the Denver metro area for the duration of the study

Exclusion Criteria

  • Subjects with known cirrhosis
  • Subjects with a history of moderate to severe anemia at screening as defined by: * Moderate: Hemoglobin 8-9.5 g/dL * Severe: Hemoglobin < 8 g/dL
  • Subjects with an alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 200 IU/L at screening
  • Subjects with a total bilirubin greater than 1.5 mg/dL at screening
  • Subjects with an international normalized ratio (INR) greater than 1.3 at screening
  • Subjects with a platelet count less than 125 10^9/L at screening
  • Subjects who are currently taking warfarin (acetaminophen group only)
  • Subjects with anorexia nervosa (self-reported; acetaminophen group only)
  • Subjects who weigh =< 50 kg at screening (acetaminophen group only)
  • Subjects who adhere to a fasting type diet (self-reported; acetaminophen group only)
  • Subjects with a known hypersensitivity or allergy to acetaminophen (acetaminophen group only)
  • Subjects who are currently taking isoniazid (acetaminophen group only)
  • Subjects who are currently taking disulfiram (acetaminophen group only)
  • Subjects who are pregnant or breastfeeding (female participants only)
  • Subjects who are currently enrolled in a clinical trial, have participated in a clinical trial within the 30 days prior to the procedure, or who plan to participate in a clinical trial during the 5 day post-procedure follow-up period

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Kennon Heard
Phone: 720-848-6777

PRIMARY OBJECTIVE:

I. To describe the course of acetaminophen-cysteine protein adduct (APAP-CYS) concentrations following ischemic hepatic embolization in subjects who receive 2 or 4 grams/day of acetaminophen for three days prior to the procedure.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients with metastatic hepatic tumor receive acetaminophen orally (PO) 4 times daily (QID) on days -3 to -1 prior to standard embolization. Patients with primary hepatic tumor receive acetaminophen PO twice daily (BID) on days -3 to -1 prior to standard embolization Patients also receive a medication diary to record the number of times they take acetaminophen, any other medication, or alcohol.

GROUP II: Patients undergo standard embolization.

After completion of study, patients are followed up at 9 and 14 days.

Trial Phase Phase IV

Trial Type Basic science

Lead Organization
University of Colorado Hospital

Principal Investigator
Kennon Heard

  • Primary ID 16-0031
  • Secondary IDs NCI-2018-02475
  • Clinicaltrials.gov ID NCT02911961