Radiolabeled Glass Beads 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.

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