Liver Cancer
Conditions
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Brief summary
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.
Detailed description
OBJECTIVES: Primary * Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates. * Evaluate patient experience and toxicities associated with TheraSphere® treatment. * Enter treatment experience into a liver database. Secondary * Determine the tumor response rates in patients receiving this treatment. OUTLINE: This is a humanitarian device exemption use study. Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion. After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.
Interventions
RADIATIONbrachytherapy
The target dose of TheraSphere® is 80-150Gy
RADIATIONyttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150Gy
Sponsors
City of Hope Medical Center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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: 1. first TheraSphere administration; or 2. 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
Countries
United States
Outcome results
None listed