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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039078
First received: June 6, 2002
Last updated: December 23, 2009
Last verified: December 2008
  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 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pittsburgh
Investigators
Study Chair: T. Clark Gamblin, MD UPMC Cancer Center at UPMC Presbyterian
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00039078     History of Changes
Other Study ID Numbers: CDR0000069336, PCI-IRB-0611014, PCI-IRB-000656, PCI-IRB-000871, NCI-V02-1701
Study First Received: June 6, 2002
Last Updated: December 23, 2009
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

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 24, 2014