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

• Status: Completed
• Trial end date: 2021-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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