radiolabeled glass beads (therasphere®) in treating patients with primary 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 the side effects of hepatic arterial infusion using yttrium-90 microspheres (therasphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.

objectives: * provide supervised access to yttrium-90 glass microspheres (therasphere®) for patients with unresectable hepatocellular carcinoma. * determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres. * determine the toxic effects and adverse experiences associated with this therapy in these patients. * determine the survival time of patients treated with this therapy. * determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy. * evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy. * assess the quality of life of patients treated with this therapy. outline: radioactive material yttrium-90 glass microspheres (therasphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. patients receive therasphere® via hepatic arterial infusion on day 1. this artery is accessed through the femoral artery in the groin. this procedure is generally completed on an outpatient basis. patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. patients may be re-treated at a later time. patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of hepatocellular carcinoma (hcc) * histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for hcc, and/or an elevated alpha-fetoprotein (afp) level * no significant extrahepatic disease that may represent an imminent life-threatening outcome * no evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (therasphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract patient characteristics: * ecog performance status 0-2 * no hepatic dysfunction * bilirubin ≤ 2.0 mg/dl * no vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization * no pulmonary insufficiency * no evidence of detectable technetium tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow * no contraindications to angiography * no contraindications to selective visceral catheterization * no other condition or cormorbidity that would preclude study treatment * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 30 days after study prior concurrent therapy: * at least 1 month since prior chemotherapy, radiotherapy, or surgery * no other concurrent investigational agents or anticancer therapy for hcc

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