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Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01176604
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : October 14, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.

Condition or disease Intervention/treatment Phase
Stage III Hepatocellular Carcinoma AJCC v8 Stage IIIA Hepatocellular Carcinoma AJCC v8 Stage IIIB Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IVA Hepatocellular Carcinoma AJCC v8 Stage IVB Hepatocellular Carcinoma AJCC v8 Unresectable Hepatocellular Carcinoma Radiation: Yttrium Y 90 Glass Microspheres Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Provide oversight to treatment with yttrium Y 90 glass microspheres (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 via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
Actual Study Start Date : August 4, 2010
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : April 9, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arm Intervention/treatment
Experimental: Treatment (yttrium Y 90 glass microspheres)
Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.
Radiation: Yttrium Y 90 Glass Microspheres
Given via catheter
Other Name: TheraSphere




Primary Outcome Measures :
  1. Oversight to treatment with yttrium Y 90 glass microspheres [ Time Frame: Up to 2 years ]
    Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.

  2. Patient experience [ Time Frame: Up to 2 years ]
    Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.

  3. Incidence of adverse events [ Time Frame: 30 days after each treatment ]
    Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.

  4. Overall survival [ Time Frame: Up to 2 years ]
    Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of intrahepatic 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 alphafetoprotein (AFP) and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
  • 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

Exclusion Criteria:

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)
  • Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)
  • 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
  • Clinical evidence of pulmonary insufficiency
  • Evidence of any detectable technetium-99 macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow
  • Complete occlusion of the main portal vein
  • 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
  • Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176604


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Armeen Mahvash M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01176604    
Other Study ID Numbers: 2008-0770
NCI-2018-01816 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2008-0770 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases