Liver Cancer, Metastatic Cancer
Conditions
Keywords
liver metastases, advanced 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: 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
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
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
Countries
United States