Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Liver Cancer Clinical Trial

Official title:

A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00589030
• Other study ID #: 06057
• Secondary ID: CHNMC-06057CDR00
• Status: No longer available
• Phase: N/A
• First received: January 3, 2008
• Last updated: February 13, 2017
• Start date: April 2007
• Est. completion date: September 2014

Study information

• Verified date: February 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

Primary

• Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.

• Evaluate patient experience and toxicities associated with TheraSphere® treatment.

• Enter treatment experience into a liver database.

Secondary

• Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of hepatocellular carcinoma

• Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation

• Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2

• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

• Absolute granulocyte count =<1,500/ul

• Platelet count =<75,000/ul

• Serum creatinine >= 2.0 mg/dl

• Serum bilirubin

• >= 2.0 mg/dl for bilateral treatment or lobar treatment

• >= 3.0 mg/dl for single lesion which could be treated by segmental fusion

• 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

• Portal hypertension with portal venous shunt away from the liver

• Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

1. first TheraSphere administration; or

2. cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments

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

• Significant extrahepatic disease representing an imminent life-threatening outcome

• Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)

• Active uncontrolled infection

• Significant underlying medical or psychiatric illness

• Pregnant women may not participate

• Children may not participate

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Radiation:
• brachytherapy
The target dose of TheraSphere® is 80-150Gy
• yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150Gy

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States,