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

Stage IV Uveal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01473004
• Other study ID #: 10D.95
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 31, 2011
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Stage IV Uveal Melanoma
• Uveal Neoplasms

Intervention

Device:
• Sir-Spheres®
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall Survival		2 years post treatment
Secondary	Progression Free Survival	Period of time without progression of liver metastasis	2 years post treatment
Secondary	Duration of Response		2 years post treatment

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital