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

NCT ID: NCT00589030

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS
• Study Start Date: 2007-04-30
• Study Completion Date: 2014-09-30

Brief 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.

Detailed 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.

Conditions

Liver Cancer

Interventions

brachytherapy

The target dose of TheraSphere® is 80-150Gy

Intervention Type: RADIATION

yttrium Y 90 glass microspheres

The target dose of TheraSphere® is 80-150Gy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Jen Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

CHNMC-06057

Identifier Type: -

Identifier Source: secondary_id

CDR0000579146

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2010-00429

Identifier Type: REGISTRY

Identifier Source: secondary_id

06057

Identifier Type: -

Identifier Source: org_study_id