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

This study is currently recruiting participants.

Verified December 2012 by Thomas Jefferson University

Sponsor:

Information provided by (Responsible Party):

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT01473004

First received: November 14, 2011

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 14, 2011

Last Updated Date

December 10, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical benefit rate of previously treated and naive patients [ Time Frame: 3 months post final treatment ] [ Designated as safety issue: No ]
Evaluation of clinical benefit includes status of complete and partial response as well as stable disease
Number of patients with adverse events [ Time Frame: 3 months post final treatment ] [ Designated as safety issue: Yes ]
Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473004 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]
Period of time without progression of liver metastasis
Duration of Response [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres® Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stage IV Uveal Melanoma

Intervention ^ICMJE

Device: Sir-Spheres®

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

Study Arm (s)

Experimental: Sirspheres, response evaluation

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

Intervention: Device: Sir-Spheres®

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mary Ann Laudadio, RN

215-955-9980

mary.ann.laudadio@jefferson.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01473004

Other Study ID Numbers ^ICMJE

TS001RSUM

Has Data Monitoring Committee

Yes

Responsible Party

Thomas Jefferson University

Study Sponsor ^ICMJE

Thomas Jefferson University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Takami Sato, MD	Thomas Jefferson University
Principal Investigator:	Carin Gonsalves, MD	Thomas Jefferson University

Information Provided By

Thomas Jefferson University

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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