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

Study Overview
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Brief Summary
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The purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. This radiation may cause the tumor cells to die.

Official Title
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An Open-Label, Single Institution, Phase II Study Using Radioactive Yttrium90 Microsphere (SIR-Sphere®) in Uveal Melanoma Patients With Hepatic Metastasis

Conditions
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Stage IV Uveal Melanoma

Intervention / Treatment
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* Device: Sir-Spheres®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirspheres, response evaluation<br>Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks. | Device: Sir-Spheres®<br>* Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate of previously treated and naive patients | Evaluation of clinical benefit includes status of complete and partial response as well as stable disease | 3 months post final treatment | 
| Number of patients with adverse events | Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment | 3 months post final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 years post treatment | 
| Progression Free Survival | Period of time without progression of liver metastasis | 2 years post treatment | 
| Duration of Response |  | 2 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sir-spheres, Liver Metastases, Selective internal radiation, Yttrium-90, Uveal, Melanoma, Ocular melanoma