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

Phase 2

Active, not recruiting

• Conditions: Stage IV Uveal Melanoma
• Interventions: Device: Sir-Spheres®

• Registration Number: NCT01473004
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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 cells to die.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-31
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sirspheres, response evaluation	Sir-Spheres®	Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	2 years post treatment	Period of time without progression of liver metastasis
Duration of Response	2 years post treatment
Overall Survival	2 years post treatment

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States