Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	PCI-IRB-0611014 PCI-IRB-000656, PCI-IRB-000871, NCI-V02-1701, NCT00039078

Objectives

1. Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
2. Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
3. Determine the toxic effects and adverse experiences associated with this therapy in these patients.
4. Determine the survival time of patients treated with this therapy.
5. Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
6. Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
7. Assess the quality of life of patients treated with this therapy.

Entry Criteria

Disease Characteristics:

• Confirmed diagnosis of hepatocellular carcinoma (HCC)
  • Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level



• No significant extrahepatic disease that may represent an imminent life-threatening outcome



• No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract

Prior/Concurrent Therapy:

• At least 1 month since prior chemotherapy, radiotherapy, or surgery
• No other concurrent investigational agents or anticancer therapy for HCC

Patient Characteristics:

• ECOG performance status 0-2
• No hepatic dysfunction
• Bilirubin ≤ 2.0 mg/dL
• No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization
• No pulmonary insufficiency
• No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
• No contraindications to angiography
• No contraindications to selective visceral catheterization
• No other condition or cormorbidity that would preclude study treatment
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 30 days after study

Expected Enrollment

Outcomes

Response to treatment
Survival time from treatment
Adverse experiences

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.

Carr BI: Hepatic arterial 90Yttrium glass microspheres (Therasphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients. Liver Transpl 10 (2 Suppl 1): S107-10, 2004.[PUBMED Abstract]

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.

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.

Goin JE, Salem R, Carr BI, et al.: Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: a risk-stratification analysis. J Vasc Interv Radiol 16 (2 Pt 1): 195-203, 2005.[PUBMED Abstract]

Geschwind JF, Salem R, Carr BI, et al.: Yttrium-90 microspheres for the treatment of hepatocellular carcinoma. Gastroenterology 127 (5 Suppl 1): S194-205, 2004.[PUBMED Abstract]

Salem R, Thurston KG, Carr BI, et al.: Yttrium-90 microspheres: radiation therapy for unresectable liver cancer. J Vasc Interv Radiol 13 (9 Pt 2): S223-9, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Centers

T. Clark Gamblin, MD, Protocol chair		Ph: 412-692-2001 Email: gamblintc@upmc.edu

U.S.A.
Pennsylvania
	Pittsburgh
	UPMC Liver Cancer Center
		Clinical Trials Office - UPMC Liver Cancer Center	Ph:  412-692-2001

Registry Information
Official Title		The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma
Trial Start Date		2000-08-09
Registered in ClinicalTrials.gov		NCT00039078
Date Submitted to PDQ		2002-03-05
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA14089

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