Radiolabeled Glass Beads in Treating Patients With Metastatic 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 metastatic 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 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.

Official Title
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A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

Conditions
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Liver Cancer, Metastatic 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 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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Patients<br>Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care. | Radiation: Yttrium Y 90 glass microspheres<br>* Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases, advanced adult primary liver cancer