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

Primary Purpose

Liver Cancer

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
brachytherapy
yttrium Y 90 glass microspheres
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 3, 2008
Last Updated
February 13, 2017
Sponsor
City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00589030
Brief Title
Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Official Title
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol
Study Type
Expanded Access

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
No longer available
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center

4. Oversight

5. Study Description

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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Description
The target dose of TheraSphere® is 80-150Gy
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 glass microspheres
Intervention Description
The target dose of TheraSphere® is 80-150Gy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: first TheraSphere administration; or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Chen, MD, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

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

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