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

Primary Purpose

Carcinoma, Hepatocellular, Liver Neoplasms

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

yttrium Y 90 microspheres (TheraSphere®)

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Therasphere, Yttrium, liver, cancer, radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Treatment Centers of America at Southwestern Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TheraSphere

Arm Description

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

Outcomes

Primary Outcome Measures

Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity

Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Survival time

Secondary Outcome Measures

Full Information

NCT ID

NCT00493883

First Posted

June 26, 2007

Last Updated

May 12, 2015

Sponsor

Southwestern Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00493883

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Southwestern Regional Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular, Liver Neoplasms

Keywords

Therasphere, Yttrium, liver, cancer, radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TheraSphere

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

yttrium Y 90 microspheres (TheraSphere®)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Time Frame

2 years

Title

Survival time

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James P Flynn, MD

Organizational Affiliation

Southwestern Regional Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Treatment Centers of America at Southwestern Regional Medical Center

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11229728

Citation

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. doi: 10.1088/0031-9155/46/2/315.

Results Reference

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PubMed Identifier

11951213

Citation

Herba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Semin Oncol. 2002 Apr;29(2):152-9. doi: 10.1053/sonc.2002.31672.

Results Reference

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PubMed Identifier

12029557

Citation

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. doi: 10.1007/s00259-002-0787-4. Epub 2002 Mar 29.

Results Reference

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PubMed Identifier

15713920

Citation

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. doi: 10.1097/01.RVI.0000142602.79459.90.

Results Reference

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PubMed Identifier

16002501

Citation

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. doi: 10.1097/01.RVI.0000161142.12822.66.

Results Reference

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PubMed Identifier

16105922

Citation

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. doi: 10.1097/01.RVI.0000168104.32849.07.

Results Reference

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PubMed Identifier

16371529

Citation

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. doi: 10.1097/01.RVI.0000184594.01661.81.

Results Reference

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PubMed Identifier

16371530

Citation

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. doi: 10.1097/01.RVI.0000179815.44868.66.

Results Reference

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PubMed Identifier

16999596

Citation

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. doi: 10.1089/cbr.2006.21.305.

Results Reference

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PubMed Identifier

17056999

Citation

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. doi: 10.1097/01.RVI.0000236744.34720.73.

Results Reference

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PubMed Identifier

16729228

Citation

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): assessment of hepatic arterial embolization. Cardiovasc Intervent Radiol. 2006 Jul-Aug;29(4):522-9. doi: 10.1007/s00270-005-0171-4.

Results Reference

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

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