Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

Inclusion 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