Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary 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 the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma. Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres. Determine the toxic effects and adverse experiences associated with this therapy in these patients. Determine the survival time of patients treated with this therapy. Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy. Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy. Assess the quality of life of patients treated with this therapy. OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time. Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.

Official Title
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The Use of TheraSphere® for the 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 hepatocellular carcinoma (HCC) Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level No significant extrahepatic disease that may represent an imminent life-threatening outcome No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract PATIENT CHARACTERISTICS: ECOG performance status 0-2 No hepatic dysfunction Bilirubin ≤ 2.0 mg/dL No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization No pulmonary insufficiency No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow No contraindications to angiography No contraindications to selective visceral catheterization No other condition or cormorbidity that would preclude study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 30 days after study PRIOR CONCURRENT THERAPY: At least 1 month since prior chemotherapy, radiotherapy, or surgery No other concurrent investigational agents or anticancer therapy for HCC

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: yttrium Y 90 glass microspheres|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment |  |  | 
| Survival time from treatment |  |  | 
| Adverse experiences |  |  | 

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