An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres® Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis
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