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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Radiation: brachytherapy
* Radiation: yttrium Y 90 glass microspheres


Participation Criteria
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Eligibility Criteria
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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: first TheraSphere administration; or 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: brachytherapy|The target dose of TheraSphere® is 80-150Gy|
|Radiation: yttrium Y 90 glass microspheres|The target dose of TheraSphere® is 80-150Gy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer