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

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.

Eligibility Criteria:
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