Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma

A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.

PRIMARY OBJECTIVES:

I. Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

OUTLINE:

Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.

Inclusion Criteria:

• Diagnosis of intrahepatic HCC. 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

Exclusion Criteria:

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)

• Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)

• 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

• Clinical evidence of pulmonary insufficiency

• Evidence of any detectable technetium-99 macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow

• Complete occlusion of the main portal vein

• 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

• Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein