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

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

Tracking Information

• First Submitted Date: November 14, 2011
• First Posted Date: November 17, 2011
• Last Update Posted Date: October 31, 2019
• Actual Study Start Date: October 31, 2011
• Estimated Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01473004 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stage IV Uveal Melanoma

Intervention

Device: Sir-Spheres®

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

Study Arms

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 14, 2011): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2021
• Estimated Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01473004
• Other Study ID Numbers: 10D.95
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
• Study Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: Not Provided

Investigators

• 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