radiolabeled glass beads in treating patients with metastatic liver cancer that cannot be removed by surgery

Conditions: Liver Cancer; Metastatic 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 metastatic liver cancer that cannot be removed by surgery.

objectives: * provide supervised access to treatment with yttrium y 90 glass microspheres (therasphere®) to eligible patients who are not candidates for surgical resection of metastatic intrahepatic carcinoma. * evaluate patient experience and toxicities associated with yttrium y 90 glass microspheres 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 therapy 4-12 weeks after initial treatment at the discretion of the study physician. after completion of study therapy, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of metastatic 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 * fda approval to receive compassionate use of yttrium y 90 glass microspheres * no significant extrahepatic disease representing an imminent life-threatening outcome * no evidence of potential delivery of \> 16.5 mci (30 gy absorbed dose) of radiation to the lungs on either of the following: * first administration of yttrium y 90 glass microspheres (therasphere ®) * cumulative delivery of radiotherapy to the lungs over multiple treatments patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 3 months * absolute granulocyte count ≥ 1,500/µl * platelet count ≥ 25,000/μl * 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) * no contraindication to angiography or selective visceral catheterization, including any of the following: * 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 * no severe liver dysfunction or pulmonary insufficiency * no active uncontrolled infection * no significant underlying medical or psychiatric illness * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no evidence of any detectable technetium-99 macroaggregated albumin (tc-99 maa) flow to the stomach or duodenum after application of established angiographic techniques to stop such flow * no comorbid disease or condition that would preclude safe delivery of yttrium y 90 glass microspheres and place patient at undue risk prior concurrent therapy: * see disease characteristics * more than 4 weeks since prior radiotherapy * more than 2 weeks since prior surgery * at least 2 weeks since prior radiosensitizing chemotherapy * more than 6 weeks since prior carmustine (bcnu) or mitomycin c * no other concurrent cancer therapy

Keywords: liver metastases advanced adult primary liver cancer