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Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
  • The cancer is unresectable.
  • All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Age 18 years or older.
  • Able to understand informed consent.

Exclusion Criteria:

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

    • single TheraSphere administration; or
    • cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
  • Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
  • Previous radiation therapy to the lungs and/or to the upper abdomen
  • Pregnancy
  • Symptomatic lung disease.
  • Significant extrahepatic disease representing an imminent life-threatening outcome.
  • Active uncontrolled infection

  • Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

    • Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
    • Serum bilirubin greater than 2 mg/dl
    • Infiltrative tumor on imaging
    • Tumor volume greater than 70% of liver volume
    • Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yttrium-90 liver radioembolization

Arm Description

Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain

Secondary Outcome Measures

Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD). Complete Response (CR), -Target Lesions: Disappearance of all target lesions. -Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) < %30 decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) -Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy

Full Information

First Posted
February 1, 2011
Last Updated
April 18, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01290523
Brief Title
Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma
Official Title
Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Off study clinical use of Y90 glass microspheres (TheraSphere)
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yttrium-90 liver radioembolization
Arm Type
Experimental
Arm Description
Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Intervention Type
Device
Intervention Name(s)
Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
Intervention Description
Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD). Complete Response (CR), -Target Lesions: Disappearance of all target lesions. -Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) < %30 decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) -Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. The cancer is unresectable. All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Age 18 years or older. Able to understand informed consent. Exclusion Criteria: Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: single TheraSphere administration; or cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments. Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. Previous radiation therapy to the lungs and/or to the upper abdomen Pregnancy Symptomatic lung disease. Significant extrahepatic disease representing an imminent life-threatening outcome. Active uncontrolled infection Any pre-treatment laboratory findings within 30 days of treatment demonstrating: Aspartate or alanine aminotransferase level greater than 5 times upper normal limit. Serum bilirubin greater than 2 mg/dl Infiltrative tumor on imaging Tumor volume greater than 70% of liver volume Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Fidelman, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

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