SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver (NCT01473004) | Clinical Trial Compass
CompletedPhase 2
SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
United States48 participantsStarted 2011-10-31
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* prev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Benefit Rate of Previously Treated and Naive Patients
Timeframe: 3 months post final treatment, an average of 4 months
2
Number of Patients With Adverse Events
Timeframe: 3 months post final treatment, an average of 4 months