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

NCT ID: NCT00039078

Last Updated: 2017-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2000-08-31

Brief Summary

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.

Detailed Description

OBJECTIVES:

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

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.

Conditions

Liver Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

yttrium Y 90 glass microspheres

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

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

PRIOR CONCURRENT THERAPY:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allan Tsung

OTHER

Sponsor Role: lead

Responsible Party

Allan Tsung

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

T. Clark Gamblin, MD

Role: STUDY_CHAIR

UPMC Cancer Center at UPMC Presbyterian

Locations

UPMC Liver Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15713920 (View on PubMed)

Geschwind JF, Salem R, Carr BI, Soulen MC, Thurston KG, Goin KA, Van Buskirk M, Roberts CA, Goin JE. Yttrium-90 microspheres for the treatment of hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S194-205. doi: 10.1053/j.gastro.2004.09.034.

Reference Type: BACKGROUND

PMID: 15508085 (View on PubMed)

Salem R, Thurston KG, Carr BI, Goin JE, Geschwind JF. Yttrium-90 microspheres: radiation therapy for unresectable liver cancer. J Vasc Interv Radiol. 2002 Sep;13(9 Pt 2):S223-9. doi: 10.1016/s1051-0443(07)61790-4.

Reference Type: BACKGROUND

PMID: 12354840 (View on PubMed)

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. doi: 10.1002/lt.20036.

Reference Type: RESULT

PMID: 14762849 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

CDR0000069336

Identifier Type: REGISTRY

Identifier Source: secondary_id

PCI-IRB-000656

Identifier Type: -

Identifier Source: secondary_id

PCI-IRB-000871

Identifier Type: -

Identifier Source: secondary_id

NCI-V02-1701

Identifier Type: -

Identifier Source: secondary_id

PCI-IRB-0611014

Identifier Type: -

Identifier Source: org_study_id