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.
- 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.
- 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.
- 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
- 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,
- 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