Status:
COMPLETED
Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 hepatocel...
Detailed Description
Because Hepatocellular carcinoma (HCC) grows by forming new blood vessels liver transplant (OLT) offers the best chance for long term survival. However, with the growing number of patients who require...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00846131
Start Date
February 1 2009
End Date
September 1 2016
Last Update
September 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611