yttrium y 90 radiolabeled glass beads in treating patients with liver cancer that cannot be removed by surgery

Conditions: Liver Cancer

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.

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.

Eligibility 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

Keywords: adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer