Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity. The study has the following objectives: * Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver. * Evaluate patient experience and toxicities associated with TheraSphere treatment * Evaluate predisposing factors that may influence results and toxicity

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Age \>= 18.
2. Cancer visible in liver on CT,MR,US or PET scan.
3. Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.
4. Life expectancy greater than 2 months
5. Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)
6. Patients have tried and/or are aware of all FDA approved therapies for their condition.

Exclusion Criteria:

1. Vascular shunt that cannot be corrected.
2. Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.
3. Pregnancy
4. Hematologic primary such as lymphoma, leukemia, myeloma.
5. Body weight 300 lbs. and above
6. Evidence of portal hypertension, splenomegaly or ascites.

• BACKGROUNDCampbell AM, Bailey IH, Burton MA. Tumour dosimetry in human liver following hepatic yttrium-90 microsphere therapy. Phys Med Biol. 2001 Feb;46(2):487-98. doi: 10.1088/0031-9155/46/2/315. PMID 11229728
• BACKGROUNDHerba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Semin Oncol. 2002 Apr;29(2):152-9. doi: 10.1053/sonc.2002.31672. PMID 11951213
• BACKGROUNDWong CY, Salem R, Raman S, Gates VL, Dworkin HJ. Evaluating 90Y-glass microsphere treatment response of unresectable colorectal liver metastases by [18F]FDG PET: a comparison with CT or MRI. Eur J Nucl Med Mol Imaging. 2002 Jun;29(6):815-20. doi: 10.1007/s00259-002-0787-4. Epub 2002 Mar 29. PMID 12029557
• BACKGROUNDGoin JE, Salem R, Carr BI, Dancey JE, Soulen MC, Geschwind JF, Goin K, Van Buskirk M, Thurston K. Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: a risk-stratification analysis. J Vasc Interv Radiol. 2005 Feb;16(2 Pt 1):195-203. doi: 10.1097/01.RVI.0000142602.79459.90. PMID 15713920
• BACKGROUNDMurthy R, Xiong H, Nunez R, Cohen AC, Barron B, Szklaruk J, Madoff DC, Gupta S, Wallace MJ, Ahrar K, Hicks ME. Yttrium 90 resin microspheres for the treatment of unresectable colorectal hepatic metastases after failure of multiple chemotherapy regimens: preliminary results. J Vasc Interv Radiol. 2005 Jul;16(7):937-45. doi: 10.1097/01.RVI.0000161142.12822.66. PMID 16002501
• BACKGROUNDWong CY, Qing F, Savin M, Campbell J, Gates VL, Sherpa KM, Lewandowski RJ, Nagle C, Salem R. Reduction of metastatic load to liver after intraarterial hepatic yttrium-90 radioembolization as evaluated by [18F]fluorodeoxyglucose positron emission tomographic imaging. J Vasc Interv Radiol. 2005 Aug;16(8):1101-6. doi: 10.1097/01.RVI.0000168104.32849.07. PMID 16105922
• BACKGROUNDSalem R, Lewandowski RJ, Atassi B, Gordon SC, Gates VL, Barakat O, Sergie Z, Wong CY, Thurston KG. Treatment of unresectable hepatocellular carcinoma with use of 90Y microspheres (TheraSphere): safety, tumor response, and survival. J Vasc Interv Radiol. 2005 Dec;16(12):1627-39. doi: 10.1097/01.RVI.0000184594.01661.81.