Status:
COMPLETED
SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
Lead Sponsor:
Thomas Jefferson University
Conditions:
Stage IV Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is an open-label, uncontrolled single institution phase II study for metastatic uveal melanoma. Uveal melanoma patients who received one or less prior trans-arterial embolization treatment of hep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01473004
Start Date
October 31 2011
End Date
December 31 2024
Last Update
November 14 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107