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