Radiolabeled Glass Beads for the Treatment of Patients with Advanced or Metastatic and Unresectable Hepatocellular Cancer

Inclusion Criteria

• Diagnosis of advanced or metastatic HCC, metastatic colorectal cancer, metastatic neuroendocrine carcinoma, metastatic ocular melanoma, metastatic adrenal cancer, or other metastatic lesions thought to be radiosensitive; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (AFP) and clinical findings; guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
• Life expectancy >= 3 months
• > 4 weeks since prior radiation, surgery or chemotherapy
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
• Ineligible for surgical resection

Exclusion Criteria

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL) (within 15 days of treatment)
• Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment)
• Any contraindications to angiography and hepatic artery catheterization such as: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization
• Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
• Evidence of pulmonary insufficiency
• Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
• Pregnancy