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Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

Sponsor
Leo W. Jenkins Cancer Center (Other)
Overall Status
No longer available
CT.gov ID
NCT00701168
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.

Condition or Disease Intervention/Treatment Phase
  • Device: yttrium Y 90 microspheres (Therasphere®)

Study Design

Study Type:
Expanded Access
Official Title:
A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Confirmed diagnosis of primary or metastatic intrahepatic carcinoma

    • The cancer must be unresectable with limited established treatment options

    • ECOG Performance Status Score 0-2

    • Age 19 years or older

    • Able to comprehend and provide written informed consent

    Exclusion Criteria:

    • Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

    • Absolute granulocyte count ≤ 1,500/ul

    • Platelet count ≤ 75,000/ul

    • Serum creatinine > 2.0 mg/dl

    • Serum bilirubin ≥ 2.0 mg/dl

    • 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

    • Bleeding, diathesis, not correctable by usual forms of therapy

    • Severe peripheral vascular disease that would preclude catheterization

    • Substantial venous shunt away from the liver

    • Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments

    • Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow

    • Significant extrahepatic disease representing an imminent life- threatening situation outcome

    • Severe liver dysfunction or pulmonary insufficiency

    • Active uncontrolled infection

    • Significant underlying medical or psychiatric illness

    • Pregnant women may not participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leo W Jenkins Cancer Center at East Carolina University School of Medicine Greenville North Carolina United States 27834

    Sponsors and Collaborators

    • Leo W. Jenkins Cancer Center

    Investigators

    • Principal Investigator: Suzanne Russo, MD, East Carolina University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Leo W. Jenkins Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00701168
    Other Study ID Numbers:
    • LJCC 07-04
    First Posted:
    Jun 19, 2008
    Last Update Posted:
    Aug 23, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Aug 23, 2017