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

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	Radiation: yttrium Y 90 glass microspheres	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Eye Wear Liver Cancer Methamphetamine Radiation Therapy Surgery

Drug Information available for: Methamphetamine hydrochloride TheraSphere Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response to treatment [ Designated as safety issue: No ]
Survival time from treatment [ Designated as safety issue: No ]
Adverse experiences [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	August 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039078

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

Sponsors and Collaborators

UPMC Cancer Centers

Investigators

Study Chair:

T. Clark Gamblin, MD

UPMC Cancer Center at UPMC Presbyterian

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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, 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.

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.

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. Review.

Study ID Numbers:	CDR0000069336, PCI-IRB-0611014, PCI-IRB-000656, PCI-IRB-000871, NCI-V02-1701
Study First Received:	June 6, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00039078 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Recurrence
Carcinoma
Liver Neoplasms
Methamphetamine

Digestive System Diseases
Gastrointestinal Neoplasms
Amphetamine
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009