Phase 2
N=48
SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
Stage IV Uveal Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01473004 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Clinical Benefit Rate of Previously Treated and Naive Patients — 0; 0; 7; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sir-Spheres® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate of Previously Treated and Naive Patients |
0; 0; 7; 6; 13; 8 | — |
| PRIMARY Number of Patients With Adverse Events |
16; 15 | — |
| SECONDARY Overall Survival |
18.9; 19.1 | — |
| SECONDARY Progression Free Survival |
8.1; 5.2 | — |
| SECONDARY Duration of Response |
8.1; 5.2 | — |
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).
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 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
Data sourced from ClinicalTrials.gov (NCT01473004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.