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

NCT01290536 | Completed Phase 2 Results DMC

• 1 other identifier: UCSF-SIRT-Metastases
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

Liver metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic Response

  6 months after treatment

Study Arms (1)

Yttrium-90 liver radioembolization

EXPERIMENTAL

Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)

Interventions

Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) DEVICE

Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery

Yttrium-90 liver radioembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicholas Fidelman, MD: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Melanoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases

Results Point of Contact

• Title: Nicholas Fidelman, MD
• Organization: University of California San Francisco

Nicholas.Fidelman@ucsf.edu

1-415-353-1300

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 7, 2011
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 1, 2019
• Results First Posted: December 22, 2014

Record last verified: 2019-02