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

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

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: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

OBJECTIVES:

• Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection.
• Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) 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 treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of 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

• No significant extrahepatic disease representing an imminent life-threatening outcome

• No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:

  • First yttrium Y 90 glass microspheres (TheraSphere®) administration
  • Cumulative delivery of radiation to the lungs over multiple treatments

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-2
• Absolute granulocyte count ≥ 1,500/μL
• Platelet count > 25,000/μL
• Serum 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)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion criteria:

• Any of the following contraindications to angiography and selective visceral catheterization:

  • 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

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

• Severe liver dysfunction or pulmonary insufficiency

• Active uncontrolled infection

• Significant underlying medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior and no other concurrent anticancer therapy