Yttrium Y 90 Glass Microspheres in Treating Participants With Unresectable Hepatocellular Carcinoma

PRIMARY OBJECTIVES:

I. Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to
eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical
resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere
treatment.

OUTLINE:

Participants receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0.
Participants may receive additional treatments at 4-12 week intervals until all tumors in the
liver have been treated in the absence of disease progression or unaccepted toxicity.

After completion of study treatment, participants are followed up at 3-6 weeks, then annually
for up to 2 years.

Inclusion Criteria:

- Diagnosis of unresectable intrahepatic HCC. The histopathology confirmation criterion
may be waived in patients with a radiographically identifiable liver mass, known
laboratory or clinical risk factors for cancer or elevated tumor markers such as
alphafetoprotein (AFP)^21 and clinical findings. Guidelines from the American
Association for the Study of Liver Diseases (AASLD) and the European Association for
the Study of the Liver (EASL) describe in detail the approach and algorithm for
diagnosing HCC

- Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2

- Life expectancy >= 3 months

- > 4 weeks since prior radiation, surgery or chemotherapy

- Able to comprehend and provide written informed consent in accordance with
institutional and federal guidelines

Exclusion Criteria:

- Within 15 days of treatment demonstrating liver dysfunction: Aspartate
aminotransferase (AST) (Serum Glutamic-Oxalocetic Transaminase - SGOT) or alanine
aminotransferase (ALT) (Serum Glutamic-Pyruvic Transaminase - SGPT) > 5 times Upper
Normal Limit (UNL)

- Within 15 days of treatment demonstrating liver dysfunction: Serum bilirubin > 2.0
mg/dl (unless segmental infusion is planned)

- Any contraindications to angiography and hepatic artery catheterization such as:
History of severe allergy or intolerance to any contrast media, narcotics, sedatives,
or atropine that cannot be corrected or premedicated; Bleeding diathesis, not
correctable by usual forms of therapy; Severe peripheral vascular disease that would
preclude catheterization

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiation to the lungs in a single treatment

- Clinical evidence of pulmonary insufficiency

- Evidence of any detectable Technetium-99 Macroaggregated Albumin (Tc-99m MAA) flow to
the stomach or duodenum, after application of established angiographic techniques to
stop or mitigate such flow

- Complete occlusion of the main portal vein

- Significant extrahepatic disease representing an imminent life-threatening outcome

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness

- Co-morbid disease of condition that would preclude safe delivery of TheraSphere
treatment or, in the judgment of the physician, place the patient at undue risk

- Pregnancy

- Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the
target liver volume, or tumor nodules too numerous to count, or tumor volume > 50%
combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein