Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290536
• Other study ID #: UCSF-SIRT-Metastases
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: February 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cholangiocarcinoma
• Colorectal Neoplasms
• Melanoma
• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas Fidelman, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.	6 months
Secondary	Radiographic Response	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.	6 months after treatment