search
Back to results

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

Primary Purpose

Stage IV Uveal Melanoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sir-Spheres®
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Uveal Melanoma focused on measuring Sir-spheres, Liver Metastases, Selective internal radiation, Yttrium-90, Uveal, Melanoma, Ocular melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sirspheres, response evaluation

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical benefit rate of previously treated and naive patients
Evaluation of clinical benefit includes status of complete and partial response as well as stable disease
Number of patients with adverse events
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
Progression Free Survival
Period of time without progression of liver metastasis
Duration of Response

Full Information

First Posted
November 14, 2011
Last Updated
December 20, 2022
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
search

1. Study Identification

Unique Protocol Identification Number
NCT01473004
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 31, 2011 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Uveal Melanoma
Keywords
Sir-spheres, Liver Metastases, Selective internal radiation, Yttrium-90, Uveal, Melanoma, Ocular melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sirspheres, response evaluation
Arm Type
Experimental
Arm Description
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
Intervention Type
Device
Intervention Name(s)
Sir-Spheres®
Intervention Description
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
Primary Outcome Measure Information:
Title
Clinical benefit rate of previously treated and naive patients
Description
Evaluation of clinical benefit includes status of complete and partial response as well as stable disease
Time Frame
3 months post final treatment
Title
Number of patients with adverse events
Description
Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment
Time Frame
3 months post final treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
2 years post treatment
Title
Progression Free Survival
Description
Period of time without progression of liver metastasis
Time Frame
2 years post treatment
Title
Duration of Response
Time Frame
2 years post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takami Sato, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carin Gonsalves, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

We'll reach out to this number within 24 hrs