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