SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
This study is currently recruiting participants.
Verified December 2012 by Thomas Jefferson University
Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01473004
First received: November 14, 2011
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Uveal Melanoma |
Device: Sir-Spheres® |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres® Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- Clinical benefit rate of previously treated and naive patients [ Time Frame: 3 months post final treatment ] [ Designated as safety issue: No ]Evaluation of clinical benefit includes status of complete and partial response as well as stable disease
- Number of patients with adverse events [ Time Frame: 3 months post final treatment ] [ Designated as safety issue: Yes ]Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment
Secondary Outcome Measures:
- Overall Survival [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]Period of time without progression of liver metastasis
- Duration of Response [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sirspheres, response evaluation
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
|
Device: Sir-Spheres®
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473004
Contacts
| Contact: Mary Ann Laudadio, RN | 215-955-9980 | mary.ann.laudadio@jefferson.edu |
Locations
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Mary Ann Laudadio, RN 215-955-9980 mary.ann.laudadio@jefferson.edu | |
| Principal Investigator: Takami Sato, MD | |
| Principal Investigator: Carin Gonsalves, MD | |
| Sub-Investigator: David Eschelman, MD | |
| Sub-Investigator: Rani Anne, MD | |
Sponsors and Collaborators
Thomas Jefferson University
Investigators
| Principal Investigator: | Takami Sato, MD | Thomas Jefferson University |
| Principal Investigator: | Carin Gonsalves, MD | Thomas Jefferson University |
More Information
No publications provided
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT01473004 History of Changes |
| Other Study ID Numbers: | TS001RSUM |
| Study First Received: | November 14, 2011 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Thomas Jefferson University:
|
Sir-spheres Liver Metastases Selective internal radiation Yttrium-90 |
Uveal Melanoma Ocular melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013