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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), January 2009
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00530010
  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 how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.


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

MedlinePlus related topics: Cancer Eye Wear Liver Cancer Methamphetamine
Drug Information available for: Amphetamine Methamphetamine TheraSphere
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

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

Primary Outcome Measures:
  • Proportion of patients completing scheduled treatment plan [ Designated as safety issue: No ]
  • Response [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Adverse experiences [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: December 2004
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection.
  • Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. 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 at 2 weeks, 30 days, and then once a year for approximately 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 intrahepatic carcinoma

    • Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
  • Unresectable disease
  • No portal hypertension with portal venous shunt away from the liver
  • No significant extrahepatic disease representing an imminent life-threatening outcome
  • No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:

    • First yttrium Y 90 glass microspheres (TheraSphere®) administration
    • Cumulative delivery of radiation to the lungs over multiple treatments

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Absolute granulocyte count ≥ 1,500/μL
  • Platelet count > 25,000/μL
  • Serum creatinine < 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
  • Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Any of the following contraindications to angiography and selective visceral catheterization:

    • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques
    • Bleeding diathesis, not correctable by usual forms of therapy
    • Severe peripheral vascular disease that would preclude catheterization
  • Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior and no other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530010

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Riad Salem, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Riad Salem )
Study ID Numbers: CDR0000564718, NU-1365-001
Study First Received: September 13, 2007
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00530010  
Health Authority: Unspecified

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

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009