Clinical trial · Interventional
SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
An Open-Label, Single Institution, Phase II Study Using Radioactive Yttrium90 Microsphere (SIR-Sphere®) in Uveal Melanoma Patients With Hepatic Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sir-Spheres® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: no prior intra-hepatic arterial treatment
- description
- 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.
- interventionNames
- Device: Sir-Spheres®
- type
- EXPERIMENTAL
- label
- Group B: one prior hepatic trans-arterial embolization treatment
- description
- 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.
- interventionNames
- Device: Sir-Spheres®
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available