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Brachytherapy
SIR-Spheres® Radiotherapy for Uveal Melanoma
Phase 2
Waitlist Available
Led By Takami Sato, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trialtests if radiation can kill tumor cells by targeting the blood vessels around them.
Who is the study for?
This trial is for adults with uveal melanoma that has spread to the liver. Participants must have at least one measurable liver lesion, good liver and kidney function, no prior specific treatments like hepatic perfusion or recent chemotherapy, and an ECOG performance status of 0-1 indicating they are fully active or restricted in physically strenuous activity.
What is being tested?
The study tests if SIR-Spheres®, tiny radioactive beads delivered directly into the liver's blood vessels, can shrink tumors in patients with eye melanoma that has spread to the liver. The treatment aims to kill tumor cells by providing targeted radiation.
What are the potential side effects?
Potential side effects may include abdominal pain or discomfort, nausea, fever, fatigue due to radiation exposure; there could also be risks associated with the procedure such as infection or damage to non-targeted organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate of previously treated and naive patients
Number of patients with adverse events
Secondary study objectives
Progression Free Survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sirspheres, response evaluationExperimental Treatment1 Intervention
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
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Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
163 Previous Clinical Trials
10,972 Total Patients Enrolled
Takami Sato, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
236 Total Patients Enrolled
Carin Gonsalves, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
578 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a single liver tumor that can be removed with surgery.You have received isolated hepatic perfusion treatment before.You have received chemotherapy in the two weeks before the study starts.You have a condition where blood bypasses the lungs more than usual, as shown in a special lung scan.Your body has extra blood vessels that may cause the study drug to go to the wrong places in your body.You need to have been diagnosed with advanced melanoma that has spread to the liver and the diagnosis has been confirmed by tissue testing.You have liver failure with symptoms like swollen belly and brain problems related to liver issues.Cancer has spread to other parts of the body and needs treatment beyond the liver in the last 3 months.You have a brain tumor that hasn't been treated yet.Your main portal vein is blocked, or you don't have enough extra blood vessels to compensate for the blockage.Your liver must be working well, with low bilirubin and high albumin levels.You had a heart attack in the last 6 months.You have medical problems that may make you live less than 6 months.You had radiation treatment that included your liver.You have a blockage in your bile duct, a stent in place, or have had biliary surgery except for gallbladder removal.You have a severe, uncontrolled tendency to bleed or are currently experiencing bleeding in your stomach or intestines.You need to have a liver lesion that can be measured and has not been treated before, and it should not involve more than half of the liver.Your kidneys, white blood cell count, and platelet count must be within certain healthy ranges.You have high blood pressure that is not under control, or you have congestive heart failure.You had a serious allergic reaction to iodine contrast in the past.You should be in good physical shape with no or minimal impact on daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Sirspheres, response evaluation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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