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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473004
Recruitment Status : Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : October 31, 2019
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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 : October 31, 2011
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021

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.

Primary Outcome Measures :
  1. Clinical benefit rate of previously treated and naive patients [ Time Frame: 3 months post final treatment ]
    Evaluation of clinical benefit includes status of complete and partial response as well as stable disease

  2. Number of patients with adverse events [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: 2 years post treatment ]
  2. Progression Free Survival [ Time Frame: 2 years post treatment ]
    Period of time without progression of liver metastasis

  3. Duration of Response [ Time Frame: 2 years post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473004

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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
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Principal Investigator: Takami Sato, MD Thomas Jefferson University
Principal Investigator: Carin Gonsalves, MD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University Identifier: NCT01473004     History of Changes
Other Study ID Numbers: 10D.95
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Liver Metastases
Selective internal radiation
Ocular melanoma
Additional relevant MeSH terms:
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Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases