Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
Condition: Colorectal Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Melanoma; Breast Cancer
MeSH terms: Breast Neoplasms; Melanoma; Cholangiocarcinoma; Neuroendocrine Tumors; Colorectal Neoplasms
Intervention: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Intervention description: Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver metastases

Summary:

      This is a prospective pilot study designed to document safety and efficacy of liver-directed
      therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer
      metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or
             breast malignancy with liver dominant disease. Diagnosis may be made by histo- or
             cyto-pathology, or by clinical and imaging criteria.

          -  The cancer is unresectable.

          -  All patients must be off all chemotherapeutic regimens for 30 days prior to and 30
             days after TheraSphere treatment. Concurrent therapy with octreotide is permitted,
             when appropriate.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          -  Age 18 years or older.

          -  Able to understand informed consent.

        Exclusion Criteria:

          -  Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
             radiation to the lungs on either:

               -  single TheraSphere administration; or

               -  cumulative delivery of radiation to the lungs greater than 50 Gy over multiple
                  treatments.

          -  Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or
             duodenum, after application of established angiographic techniques to stop such
             deposition.

          -  Previous radiation therapy to the lungs and/or to the upper abdomen

          -  Pregnancy

          -  Symptomatic lung disease.

          -  Significant extrahepatic disease representing an imminent life-threatening outcome.

          -  Active uncontrolled infection

          -  Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

               -  Aspartate or alanine aminotransferase level greater than 5 times upper normal
                  limit.

               -  Serum bilirubin greater than 2 mg/dl

               -  Infiltrative tumor on imaging

               -  Tumor volume greater than 70% of liver volume

               -  Tumor volume greater than 50% of liver volume and serum albumin level less than 3
                  mg/dL