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Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
First Received: January 3, 2008   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00589030
  Purpose

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: This phase II trial is studying the side effects and how well yttrium Y 90 radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.


Condition Intervention Phase
Liver Cancer
Radiation: brachytherapy
Radiation: yttrium Y 90 glass microspheres
Phase II

MedlinePlus related topics: Cancer Eye Wear Liver Cancer Methamphetamine Radiation Therapy Surgery
Drug Information available for: Methamphetamine hydrochloride TheraSphere Amphetamine Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yittrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Access to treatment [ Designated as safety issue: No ]
  • Patient experience associated with treatment [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Liver database [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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 every 3 months for up to 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Confirmed* diagnosis of hepatocellular carcinoma (HCC)

    • Stage III disease NOTE: *The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for HCC, or elevated tumor markers such as alpha-fetoprotein (clinical diagnosis).
  • Surgical evaluation by a member of the Liver Tumor Program must conclude that the patient is not a candidate for resection or ablation
  • No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

    • First TheraSphere® administration
    • Cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute granulocyte count > 1,500/µL
  • Platelet count > 75,000/μL
  • Creatinine < 3.0 mg/dL
  • Serum bilirubin < 2.0 mg/dL
  • None of the following contraindications to angiography and selective visceral catheterization allowed:

    • 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
  • No portal hypertension with portal venous shunt away from the liver
  • No evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • No significant extrahepatic disease representing an imminent life-threatening outcome
  • No severe liver dysfunction (Childs Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
  • No active uncontrolled infection
  • No significant underlying medical or psychiatric illness
  • Female patients must be post-menopausal, surgically sterile, or not pregnant
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589030

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Yi-Jen Chen, MD, PhD     800-826-4673     YiChen@coh.org    
Sponsors and Collaborators
Beckman Research Institute
Investigators
Principal Investigator: Yi-Jen Chen, MD, PhD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Comprehensive Cancer Center ( Yi-Jen Chen )
Study ID Numbers: CDR0000579146, CHNMC-06057
Study First Received: January 3, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00589030     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Recurrence
Carcinoma
Liver Neoplasms
Methamphetamine
Digestive System Diseases
Gastrointestinal Neoplasms
Amphetamine
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009