Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

• Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
• Evaluate patient experience and toxicities associated with TheraSphere® treatment.
• Enter treatment experience into a liver database.

Secondary

• Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

Inclusion Criteria:

• Confirmed diagnosis of hepatocellular carcinoma
• Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

• Absolute granulocyte count =<1,500/ul

• Platelet count =<75,000/ul

• Serum creatinine >= 2.0 mg/dl

• Serum bilirubin

  • >= 2.0 mg/dl for bilateral treatment or lobar treatment
  • >= 3.0 mg/dl for single lesion which could be treated by segmental fusion

• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine

• Bleeding, diathesis not correctable by usual forms of therapy

• Severe peripheral vascular disease that would preclude catheterization

• Portal hypertension with portal venous shunt away from the liver

• Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

  1. first TheraSphere administration; or
  2. cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments

• Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow

• Significant extrahepatic disease representing an imminent life-threatening outcome

• Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)

• Active uncontrolled infection

• Significant underlying medical or psychiatric illness

• Pregnant women may not participate

• Children may not participate