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

A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

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 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