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An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres® Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage IV Uveal Melanoma

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Trial Information

An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres® Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate of previously treated and naive patients

Outcome Description:

Evaluation of clinical benefit includes status of complete and partial response as well as stable disease

Outcome Time Frame:

3 months post final treatment

Safety Issue:

No

Principal Investigator

Takami Sato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Food and Drug Administration

Study ID:

TS001RSUM

NCT ID:

NCT01473004

Start Date:

November 2011

Completion Date:

January 2015

Related Keywords:

  • Stage IV Uveal Melanoma
  • Sir-spheres
  • Liver Metastases
  • Selective internal radiation
  • Yttrium-90
  • Uveal
  • Melanoma
  • Ocular melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541