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Trial record 1 of 1 for:    NCT01290536
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Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

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ClinicalTrials.gov Identifier: NCT01290536
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : December 22, 2014
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Nicholas Fidelman, MD, University of California, San Francisco

Brief 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).

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neuroendocrine Tumors Cholangiocarcinoma Melanoma Breast Cancer Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study
Study Start Date : May 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013


Arm Intervention/treatment
Experimental: Yttrium-90 liver radioembolization Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 6 months ]
    Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.


Secondary Outcome Measures :
  1. Radiographic Response [ Time Frame: 6 months after treatment ]
    Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Nicholas Fidelman, MD, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01290536     History of Changes
Other Study ID Numbers: UCSF-SIRT-Metastases
First Posted: February 7, 2011    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Nicholas Fidelman, MD, University of California, San Francisco:
Liver metastases
Additional relevant MeSH terms:
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Breast Neoplasms
Melanoma
Neuroendocrine Tumors
Cholangiocarcinoma
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Methamphetamine
Liver Extracts
Hematinics
Central Nervous System Stimulants
Physiological Effects of Drugs