Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

• Range of patients who can be offered TheraSphere®
• Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
• Survival time
• Determine response in relation to histology and other parameters
• Ability to tolerate repeat treatments
• Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Inclusion criteria

• Age >= 18.
• Cancer visible in liver on CT,MR,US or PET scan.
• Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.
• Life expectancy greater than 2 months
• Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)
• Patients have tried and/or are aware of all FDA approved therapies for their condition.

Exclusion criteria

• Vascular shunt that cannot be corrected.
• Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.
• Pregnancy
• Hematologic primary such as lymphoma, leukemia, myeloma.
• Body weight 300 lbs. and above
• Evidence of portal hypertension, splenomegaly or ascites.