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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Radiation: yttrium Y 90 glass microspheres


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: yttrium Y 90 glass microspheres|The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Completion | Proportion of patients completing scheduled treatment plan | Through study completion, up to 24 months or when patient discontinues treatment for whatever reason. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer