Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

NO_LONGER_AVAILABLE

Conditions studied: Liver Cancer

In brief

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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Key facts

Study ID

NCT00589030

Run by

City of Hope Medical Center

Starts

2007-04-01

Expected to finish

2014-09-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of hepatocellular carcinoma
• Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

You may not qualify if…

• Absolute granulocyte count =<1,500/ul
• Platelet count =<75,000/ul
• Serum creatinine >= 2.0 mg/dl
• Serum bilirubin
• >= 2.0 mg/dl for bilateral treatment or lobar treatment
• >= 3.0 mg/dl for single lesion which could be treated by segmental fusion
• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
• Bleeding, diathesis not correctable by usual forms of therapy
• Severe peripheral vascular disease that would preclude catheterization
• Portal hypertension with portal venous shunt away from the liver
• Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
• first TheraSphere administration; or
• cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments
• Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Pregnant women may not participate
• Children may not participate

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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