Expired Study
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Duarte, California 91010


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Confirmed diagnosis of hepatocellular carcinoma - Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation - Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2 - Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines Exclusion Criteria: - Absolute granulocyte count =<1,500/ul - Platelet count =<75,000/ul - Serum creatinine >= 2.0 mg/dl - Serum bilirubin - >= 2.0 mg/dl for bilateral treatment or lobar treatment - >= 3.0 mg/dl for single lesion which could be treated by segmental fusion - History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine - Bleeding, diathesis not correctable by usual forms of therapy - Severe peripheral vascular disease that would preclude catheterization - Portal hypertension with portal venous shunt away from the liver - Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1. first TheraSphere administration; or 2. cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments - Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow - Significant extrahepatic disease representing an imminent life-threatening outcome - Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy) - Active uncontrolled infection - Significant underlying medical or psychiatric illness - Pregnant women may not participate - Children may not participate


NCT ID:

NCT00589030


Primary Contact:

Principal Investigator
Yi-Jen Chen, MD, PhD
City of Hope Medical Center


Backup Contact:

N/A


Location Contact:

Duarte, California 91010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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