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Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

Primary Purpose

Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
yttrium Y 90 glass microspheres
laboratory biomarker analysis
TheraSphere
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma focused on measuring Humanitarian Device, Carcinoma, Hepatocellular Carcinoma, TheraSphere®, HUD

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
  • Life expectancy >= 3 months
  • > 4 weeks since prior radiation, surgery or chemotherapy
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
  • Ineligible for surgical resection

Exclusion Criteria:

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
  • Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)

  • Any contraindications to angiography and hepatic artery catheterization such as:

    • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
    • Bleeding diathesis, not correctable by usual forms of therapy
    • Severe peripheral vascular disease that would preclude catheterization
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
  • Evidence of pulmonary insufficiency
  • Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
  • Pregnancy

Sites / Locations

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (yttrium Y 90 glass microspheres)

Arm Description

Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

Outcomes

Primary Outcome Measures

Response to treatment
Survival time
Adverse experiences

Secondary Outcome Measures

Full Information

First Posted
February 24, 2014
Last Updated
September 28, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02072356
Brief Title
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Official Title
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2010 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. 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 an effective treatment for liver cancer.
Detailed Description
PRIMARY OBJECTIVES: I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates. II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. OUTLINE: Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
Keywords
Humanitarian Device, Carcinoma, Hepatocellular Carcinoma, TheraSphere®, HUD

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (yttrium Y 90 glass microspheres)
Arm Type
Experimental
Arm Description
Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 glass microspheres
Other Intervention Name(s)
TheraSphere
Intervention Description
Given Interartrial
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Other Intervention Name(s)
Correlative studies, AFP
Intervention Description
Alpha-fetoprotein assay
Intervention Type
Drug
Intervention Name(s)
TheraSphere
Intervention Description
TheraSphere is delivered into the liver tumor through a catheter placed into the hepatic artery.
Primary Outcome Measure Information:
Title
Response to treatment
Time Frame
Up to 2 years
Title
Survival time
Time Frame
Up to 2 years
Title
Adverse experiences
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2 Life expectancy >= 3 months > 4 weeks since prior radiation, surgery or chemotherapy Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines Ineligible for surgical resection Exclusion Criteria: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL) Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) Any contraindications to angiography and hepatic artery catheterization such as: History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated Bleeding diathesis, not correctable by usual forms of therapy Severe peripheral vascular disease that would preclude catheterization Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment Evidence of pulmonary insufficiency Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow Significant extrahepatic disease representing an imminent life-threatening outcome Active uncontrolled infection Significant underlying medical or psychiatric illness Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikabi Ali, M.D.
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

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