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

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Brief Title

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

Official Title

An Open-Label, Single Institution, Phase II Study Using Radioactive Yttrium90 Microsphere (SIR-Sphere®) 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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Clinical benefit rate of previously treated and naive patients

Secondary Outcome

 Overall Survival

Condition

Stage IV Uveal Melanoma

Intervention

Sir-Spheres®

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

48

Start Date

October 31, 2011

Completion Date

January 1, 2022

Primary Completion Date

December 1, 2021

Eligibility Criteria

        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

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Takami Sato, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01473004

Organization ID

10D.95


Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University


Study Sponsor

Takami Sato, MD, Principal Investigator, Thomas Jefferson University


Verification Date

December 2020