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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.
 
ClinicalTrials.gov Identifier: NCT01473004
Recruitment Status : Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information
First Submitted Date  ICMJE November 14, 2011
First Posted Date  ICMJE November 17, 2011
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE October 31, 2011
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
  • 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
  • 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
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
 (submitted: November 14, 2011)
  • Overall Survival [ Time Frame: 2 years post treatment ]
  • Progression Free Survival [ Time Frame: 2 years post treatment ]
    Period of time without progression of liver metastasis
  • Duration of Response [ Time Frame: 2 years post treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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-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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 14, 2011)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 1, 2020   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473004
Other Study ID Numbers  ICMJE 10D.95
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at 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
PRS Account Thomas Jefferson University
Verification Date October 2019

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