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Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Liver Cancer Clinical Trial

Official title:
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Clinical Trial Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Clinical Trial Description

OBJECTIVES:

Primary

- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.

- Evaluate patient experience and toxicities associated with TheraSphere® treatment.

- Enter treatment experience into a liver database.

Secondary

- Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00589030
Study type Expanded Access
Source City of Hope Medical Center
Contact
Status No longer available
Phase N/A
Start date April 2007
Completion date September 2014
View Details
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