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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01473004
First received: November 14, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Stage IV Uveal Melanoma
Device: Sir-Spheres®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres® Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: November 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473004

Contacts
Contact: Mary Ann Laudadio, RN 215-955-9980 mary.ann.laudadio@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mary Ann Laudadio, RN    215-955-9980    mary.ann.laudadio@jefferson.edu   
Principal Investigator: Takami Sato, MD         
Principal Investigator: Carin Gonsalves, MD         
Sub-Investigator: David Eschelman, MD         
Sub-Investigator: Rani Anne, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Takami Sato, MD Thomas Jefferson University
Principal Investigator: Carin Gonsalves, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01473004     History of Changes
Other Study ID Numbers: TS001RSUM
Study First Received: November 14, 2011
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Sir-spheres
Liver Metastases
Selective internal radiation
Yttrium-90
Uveal
Melanoma
Ocular melanoma

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on October 01, 2014