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

Advanced Adult Primary Liver Cancer Clinical Trial

Official title:

A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072356
• Other study ID #: OSU-10036
• Secondary ID: NCI-2012-00877
• Status: Completed
• Phase: Early Phase 1
• Start date: October 11, 2010
• Est. completion date: June 15, 2021

Study information

• Verified date: September 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

Intervention

Radiation:
• yttrium Y 90 glass microspheres
Given Interartrial

Other:
• laboratory biomarker analysis
Alpha-fetoprotein assay

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

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment		Up to 2 years
Primary	Survival time		Up to 2 years
Primary	Adverse experiences		Up to 2 years

External Links

•   The Jamesline