Clinical trial NCT01473004: SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
Official title: An Open-Label, Single Institution, Phase II Study Using Radioactive Yttrium90 Microsphere (SIR-Sphere®) in Uveal Melanoma Patients With Hepatic Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV Uveal Melanoma
Keywords: Sir-spheres
Liver Metastases
Selective internal radiation
Yttrium-90
Uveal
Melanoma
Ocular melanoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical benefit rate of previously treated and naive patients
timeFrame: 3 months post final treatment
measure: Number of patients with adverse events
timeFrame: 3 months post final treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years post treatment
measure: Progression Free Survival
timeFrame: 2 years post treatment
measure: Duration of Response
timeFrame: 2 years post treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Takami Sato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Carin Gonsalves, MD
role: PRINCIPAL_INVESTIGATOR
References: