Stage IV Uveal Melanoma Clinical Trial
Official title:
An Open-Label, Single Institution, Phase II Study Using Radioactive Yttrium90 Microsphere (SIR-Sphere®) in Uveal Melanoma Patients With Hepatic Metastasis
Verified date | December 2022 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical benefit rate of previously treated and naive patients | Evaluation of clinical benefit includes status of complete and partial response as well as stable disease | 3 months post final treatment | |
Primary | Number of patients with adverse events | Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment | 3 months post final treatment | |
Secondary | Overall Survival | 2 years post treatment | ||
Secondary | Progression Free Survival | Period of time without progression of liver metastasis | 2 years post treatment | |
Secondary | Duration of Response | 2 years post treatment |
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