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

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01473004

Collaborator

(none)

Enrollment

Location

Arm

122.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Uveal Melanoma	Device: Sir-Spheres®	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 31, 2011

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

Overall Survival [2 years post treatment]
Progression Free Survival [2 years post treatment]
Period of time without progression of liver metastasis
Duration of Response [2 years post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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