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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493883
• Other study ID #: CTCT 06-11
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 26, 2007
• Last updated: May 12, 2015
• Start date: December 2006
• Est. completion date: December 2011

Study information

• Verified date: May 2015
• Source: Southwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

1. Range of patients who can be offered TheraSphere®

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

3. Survival time

4. Determine response in relation to histology and other parameters

5. Ability to tolerate repeat treatments

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Device:
• yttrium Y 90 microspheres (TheraSphere®)
Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver

Locations

Country	Name	City	State
United States	Cancer Treatment Centers of America at Southwestern Regional Medical Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Southwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

Herba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Semin Oncol. 2002 Apr;29(2):152-9. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Epub 2002 Mar 29. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity		2 to 3 months after treatment(s) up to 2 years	No
Primary	Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.		2 years	Yes
Primary	Survival time		2 years	No

External Links

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