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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage IV Uveal Melanoma
• Intervention / Treatment: Device: Sir-Spheres®

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Carin Gonsalves, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2011
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Melanoma; Liver Metastases; Ocular melanoma; Yttrium-90; Sir-spheres; Selective internal radiation; Uveal
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: 10D.95