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

Sponsored by:	Southwestern Regional Medical Center
Information provided by:	Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:	NCT00493883

Purpose

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

Condition	Intervention	Phase
Carcinoma, Hepatocellular Liver Neoplasms	Device: yttrium Y 90 microspheres (TheraSphere®)	Phase I Phase II

MedlinePlus related topics: Cancer Eye Wear Liver Cancer Methamphetamine

Drug Information available for: Amphetamine Methamphetamine TheraSphere

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Further study details as provided by Southwestern Regional Medical Center:

Primary Outcome Measures:

Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity [ Time Frame: 2 to 3 months after treatment(s) up to 2 years ] [ Designated as safety issue: No ]
Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Survival time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver

Detailed Description:

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

Range of patients who can be offered TheraSphere®
Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
Survival time
Determine response in relation to histology and other parameters
Ability to tolerate repeat treatments
Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >= 18.
Cancer visible in liver on CT,MR,US or PET scan.
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.
Life expectancy greater than 2 months
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.)
Patients have tried and/or are aware of all FDA approved therapies for their condition.

Exclusion Criteria:

Vascular shunt that cannot be corrected.
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.
Pregnancy
Hematologic primary such as lymphoma, leukemia, myeloma.
Body weight 300 lbs. and above
Evidence of portal hypertension, splenomegaly or ascites.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493883

Contacts

Contact: Michele M Sumner, BS, CCRC	1-877-896-3698
Contact: JJ Stark, BS, CCRC	1-877-896-3698

Locations

United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional Medical Center	Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Michele M Sumner, BS, CCRC 877-896-3698
Contact: JJ Stark, BS, CCRC 1-877-896-3698
Principal Investigator: Douglas A. Kelly, M.D.

Sponsors and Collaborators

Southwestern Regional Medical Center

Investigators

Principal Investigator:

Douglas A. Kelly, M.D.

Cancer Treatment Centers of America at Southwestern Regional Medical Center

More Information

Click here for more information about this study: Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Campbell 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.

Herba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Semin Oncol. 2002 Apr;29(2):152-9.

Wong 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. Epub 2002 Mar 29.

Goin 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.

Murthy 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.

Wong 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.

Salem 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.

Lewandowski RJ, Thurston KG, Goin JE, Wong CY, Gates VL, Van Buskirk M, Geschwind JF, Salem R. 90Y microsphere (TheraSphere) treatment for unresectable colorectal cancer metastases of the liver: response to treatment at targeted doses of 135-150 Gy as measured by [18F]fluorodeoxyglucose positron emission tomography and computed tomographic imaging. J Vasc Interv Radiol. 2005 Dec;16(12):1641-51.

Sato K, Lewandowski RJ, Bui JT, Omary R, Hunter RD, Kulik L, Mulcahy M, Liu D, Chrisman H, Resnick S, Nemcek AA Jr, Vogelzang R, Salem R. Treatment of Unresectable Primary and Metastatic Liver Cancer with Yttrium-90 Microspheres (TheraSphere(R)): Assessment of Hepatic Arterial Embolization. Cardiovasc Intervent Radiol. 2006 Apr 29; [Epub ahead of print]

Wong CY, Savin M, Sherpa KM, Qing F, Campbell J, Gates VL, Lewandowski RJ, Cheng V, Thie J, Fink-Bennett D, Nagle C, Salem R. Regional yttrium-90 microsphere treatment of surgically unresectable and chemotherapy-refractory metastatic liver carcinoma. Cancer Biother Radiopharm. 2006 Aug;21(4):305-13.

Salem R, Thurston KG. Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol. 2006 Oct;17(10):1571-93. Review.

Responsible Party:	Southwestern Regional Medical Center ( Douglas A. Kelly, M.D. )
Study ID Numbers:	CTCT 06-11
Study First Received:	June 26, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00493883
Health Authority:	United States: Institutional Review Board

Keywords provided by Southwestern Regional Medical Center:

Therasphere
Yttrium
liver
cancer
radiation

Study placed in the following topic categories:

Liver Neoplasms
Methamphetamine
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Liver neoplasms
Gastrointestinal Neoplasms
Amphetamine
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009