Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

NCT ID: NCT02072356

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-11
• Study Completion Date: 2021-06-15

Brief Summary

This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. 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 an effective treatment for liver cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

OUTLINE:

Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (yttrium Y 90 glass microspheres)

Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

Group Type: EXPERIMENTAL

yttrium Y 90 glass microspheres

Intervention Type: RADIATION

Given Interartrial

laboratory biomarker analysis

Intervention Type: OTHER

Alpha-fetoprotein assay

TheraSphere

Intervention Type: DRUG

TheraSphere is delivered into the liver tumor through a catheter placed into the hepatic artery.

Interventions

yttrium Y 90 glass microspheres

Given Interartrial

Intervention Type: RADIATION

laboratory biomarker analysis

Alpha-fetoprotein assay

Intervention Type: OTHER

TheraSphere

TheraSphere is delivered into the liver tumor through a catheter placed into the hepatic artery.

Intervention Type: DRUG

Other Intervention Names

TheraSphere; Correlative studies; AFP

Eligibility Criteria

Inclusion Criteria

• Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
• Life expectancy >= 3 months
• > 4 weeks since prior radiation, surgery or chemotherapy
• Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
• Ineligible for surgical resection

Exclusion Criteria

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
• Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
• Any contraindications to angiography and hepatic artery catheterization such as:

• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
• Bleeding diathesis, not correctable by usual forms of therapy
• Severe peripheral vascular disease that would preclude catheterization
• Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
• Evidence of pulmonary insufficiency
• Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
• Pregnancy

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ali Rikabi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rikabi Ali, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2012-00877

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-10036

Identifier Type: -

Identifier Source: org_study_id