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: this phase ii trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

objectives: * provide supervised access to treatment with yttrium y 90 glass microspheres (therasphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection. * evaluate patient experience and toxicities associated with yttrium y 90 glass microspheres (therasphere®) treatment. outline: this is a humanitarian device exemption use study. patients receive yttrium y 90 glass microspheres (therasphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. after completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of intrahepatic carcinoma * histopathology confirmation may be waived in patients with a radiographically identifiable liver mass and known laboratory or clinical risk factors for cancer or elevated tumor markers such as afp * unresectable disease * no portal hypertension with portal venous shunt away from the liver * no significant extrahepatic disease representing an imminent life-threatening outcome * no evidence of potential delivery of \> 16.5 mci (30 gy absorbed dose) radiation to the lungs on either of the following: * first yttrium y 90 glass microspheres (therasphere®) administration * cumulative delivery of radiation to the lungs over multiple treatments patient characteristics: inclusion criteria: * ecog performance status 0-2 * absolute granulocyte count ≥ 1,500/μl * platelet count \> 25,000/μl * serum creatinine \< 2.0 mg/dl (unless using non-iodinated contrast or on dialysis) * serum bilirubin ≤ 3.0 mg/dl (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception exclusion criteria: * any of the following contraindications to angiography and selective visceral catheterization: * history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques * bleeding diathesis, not correctable by usual forms of therapy * severe peripheral vascular disease that would preclude catheterization * evidence of any detectable tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow * severe liver dysfunction or pulmonary insufficiency * active uncontrolled infection * significant underlying medical or psychiatric illness prior concurrent therapy: * at least 4 weeks since prior and no other concurrent anticancer therapy

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