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

NCT01473004 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: 10D.95JT 2216
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. This is a phase II clinical trial to investigate safety and efficacy of radioactive microsphere (SIR-Spheres® microspheres). Uveal melanoma patients with progressing hepatic metastases who received no more than one intra-hepatic arterial treatment will be enrolled. Patients will be first stratified into two groups: Group A, no prior intra-hepatic arterial treatment; Group B, one prior intra-hepatic arterial treatment).

Conditions

Stage IV Uveal Melanoma

Keywords

Sir-spheres; Liver Metastases; Selective internal radiation; Yttrium-90; Uveal; Melanoma; Ocular melanoma

Outcome Measures

Primary Outcomes (2)

• 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

  3 months post final treatment, an average of 4 months

• 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

  3 months post final treatment, an average of 4 months

Secondary Outcomes (3)

• Overall Survival

  From date of first SIR-Spheres® administration until the date of death from any cause, assessed up to 6 years

• Progression Free Survival

  2 years post treatment, an average of 10 months

• Duration of Response

  2 years post treatment, an average of 10 months

Study Arms (2)

Group A: no prior intra-hepatic arterial treatment

EXPERIMENTAL

Patients with no prior intra-hepatic arterial treatment will be treated with intra-hepatic arterial infusion of Yttrium-90 radioactive microspheres (SIR-Spheres® microspheres). Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.

Device: Sir-Spheres®

Group B: one prior hepatic trans-arterial embolization treatment

EXPERIMENTAL

Patients with one prior hepatic trans-arterial embolization treatment will be treated with intra-hepatic arterial infusion of Yttrium-90 radioactive microspheres (SIR-Spheres® microspheres). Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.

Device: Sir-Spheres®

Interventions

Sir-Spheres® DEVICE

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

Group A: no prior intra-hepatic arterial treatment; Group B: one prior hepatic trans-arterial embolization treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Takami Sato, MD
• Organization: Thomas Jefferson University

Takami.Sato@jefferson.edu

215-955-8874

Study Officials

• Takami Sato, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Carin Gonsalves, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: October 31, 2011
• Primary Completion: July 7, 2022
• Study Completion: December 31, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Locations

US (1)