Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

February 13, 2017 updated by: City of Hope Medical Center

A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
  • Evaluate patient experience and toxicities associated with TheraSphere® treatment.
  • Enter treatment experience into a liver database.

Secondary

  • Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of hepatocellular carcinoma
  • Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Absolute granulocyte count =<1,500/ul
  • Platelet count =<75,000/ul
  • Serum creatinine >= 2.0 mg/dl

  • Serum bilirubin

    • >= 2.0 mg/dl for bilateral treatment or lobar treatment
    • >= 3.0 mg/dl for single lesion which could be treated by segmental fusion
  • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
  • Bleeding, diathesis not correctable by usual forms of therapy
  • Severe peripheral vascular disease that would preclude catheterization
  • Portal hypertension with portal venous shunt away from the liver

  • Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

    1. first TheraSphere administration; or
    2. cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments
  • Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnant women may not participate
  • Children may not participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Yi-Jen Chen, MD, PhD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06057
  • CHNMC-06057
  • CDR0000579146 (Registry Identifier: NCI PDQ)
  • NCI-2010-00429 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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