NCT01473004CompletedPhase 2
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 · Last updated 14 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 14 Nov 2011
- Start date
- 31 Oct 2011
- Primary completion date
- 7 Jul 2022
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Melanoma
- NCT number
- NCT01473004
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 48
- From 31 Oct 2011 to the primary completion date, 7 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- solitary liver metastasis that is amenable to surgical removal
- previous treatment with isolated hepatic perfusion
- systemic chemotherapy within 2 weeks of study entry
- previous radiation that includes the liver in the main radiation field
- biliary obstruction, stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
Other illness
- failure to meet any of the inclusion criteria
- symptomatic liver failure including ascites and hepatic encephalopathy
- uncontrolled hypertension or congestive heart failure
- acute myocardial infarction within 6 months
- uncontrolled severe bleeding tendency or active GI bleed
- significant allergic reaction to iodinated contrast
Lab values
- significant shunting to the lung (\>20%) as identified on Technetium-99m-macro-aggregated albumin nuclear medicine break-through scan
Age
- children under the age of 18
Other
- unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted organs such as the GI tract
- metastasis outside of liver requiring systemic treatment within 3 months
- untreated brain metastasis
- main portal vein occlusion or inadequate collateral flow
- medical complications with implication of less than 6 month survival
- pregnant or breast-feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.