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| Sponsored by: |
UPMC Cancer Centers |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039078 |
Purpose
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 the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|
Liver Cancer |
Drug: yttrium Y 90 glass microspheres |
Phase II |
| MedlinePlus related topics: | Cancer Eye Wear Liver Cancer |
| Drug Information available for: | TheraSphere |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma |
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.
Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of hepatocellular carcinoma (HCC)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Pennsylvania | |||||
| UPMC Liver Cancer Center | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Contact: Clinical Trials Office - UPMC Liver Cancer Center 412-692-2001 | |||||
| UPMC Cancer Centers |
| Study Chair: | T. Clark Gamblin, MD | UPMC Cancer Center at UPMC Presbyterian |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Carr BI. Hepatic arterial 90Yttrium glass microspheres (Therasphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients. Liver Transpl. 2004 Feb;10(2 Suppl 1):S107-10.
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Carr BI, Sheetz M, Brown M, et al.: Hepatic arterial 90yttrium-labeled glass microspheres (Therasphere) as treatment for unresectable HCC in forty three patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-553, 2002.
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Carr BI, Brown M, France M, et al.: 90 yttrium labeled glass microspheres in the treatment of hepatocellular carcinoma: initial US experience. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2346, 2001.
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| Study ID Numbers: | CDR0000069336, PCI-IRB-0611014, PCI-IRB-000656, PCI-IRB-000871, NCI-V02-1701 |
| First Received: | June 6, 2002 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00039078 |
| Health Authority: | Unspecified |
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