SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver

Inclusion Criteria:

- must have diagnosis of metastatic melanoma liver disease by histological confirmation

- one measurable untreated or progressed liver lesion

- less than 50% liver involvement

- must have ECOG performance status of 0-1

- must have adequate renal and bone marrow function as: serum creatinine ≤ 2.0 mg/dl,
granulocyte count ≥1000/mm3 and platelet count ≥100,000/mm3

- must have adequate liver function as: total bilirubin <1.6 mg/ml and albumin >3.0 g/dl

Exclusion Criteria:

- failure to meet any of the inclusion criteria

- solitary liver metastasis that is amenable to surgical removal

- previous treatment with isolated hepatic perfusion

- systemic chemotherapy within 2 weeks of study entry

- significant shunting to the lung (>20%) as identified on
Technetium-99m-macro-aggregated albumin nuclear medicine break-through scan

- unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted
organs such as the GI tract

- symptomatic liver failure including ascites and hepatic encephalopathy

- metastasis outside of liver requiring systemic treatment within 3 months

- untreated brain metastasis

- main portal vein occlusion or inadequate collateral flow

- uncontrolled hypertension or congestive heart failure

- acute myocardial infarction within 6 months

- medical complications with implication of less than 6 month survival

- uncontrolled severe bleeding tendency or active GI bleed

- significant allergic reaction to iodinated contrast

- previous radiation that includes the liver in the main radiation field

- pregnant or breast-feeding women

- biliary obstruction, stent, or prior biliary surgery including sphincterotomy but
excluding cholecystectomy

- children under the age of 18