Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver transplantation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Adult > 18 years olf of either gender

• Diagnosis of HCC confirmed by biopsy, CT, or MRI

• Able to carry out activities of daily living, awake >50% of waking hours

• Meets eligibility for liver transplantation

• No prior treatment for HCC

• Ability to understand and sign the informed consent

• Child-bearing women and any men agree to use two forms of birth control (one of which should be a barrier method) during the course of therapy and for 8 weeks afterward.

Exclusion Criteria:

• Less than or = 18 years old

• Ineligible for transplant due to comorbid disease

• Renal Failure requiring dialysis of any kind

• Severe Cardiac disease

• History of a stroke

• Evidence of metastatic disease- or tumors that have spread outside the liver

• Known human immunodeficiency virus (HIV) infection

• Uncontrolled blood pressure (systolic > 160) despite medication(s)

• Major surgery within 4 weeks prior to the screening visit

• Active clinically serious infection

• Serious non-healing wound, ulcer, or bone fracture.

• History of gastrointestinal bleeding (GIB) within 6 weeks prior to the screening visit

• Prior transplant of any kind

• Must be able to swallow oral pills, tablets or capsules of any size

• Use of St. John's Wort or rifampin (rifampicin).

• Currently being treated with Interferon and/or Ribavirin therapy due to the thrombocytopenias, lymphopenias and anemias observed with use of these two medications.

• Known or suspected allergy to sorafenib or any agent given in the course of this trial.

• Any malabsorption problem

• Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test 7 days prior to beginning therapy.

• No potential living donor transplant (LDT-donor identified and worked up by the time of randomization into this study. If a living donor is later identified- the subject will be allowed to continue in the study. Sorafenib will be stopped at a minimum of 7 days prior to transplant surgery.

• Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a subinvestigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the study

• Inability of the potential subject to read, understand and sign the informed consent document