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

NCT02072356 | Completed Early Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: OSU-10036NCI-2012-00877
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Humanitarian Device; Carcinoma; Hepatocellular Carcinoma; TheraSphere®; HUD

Outcome Measures

Primary Outcomes (3)

• Response to treatment

  Up to 2 years

• Survival time

  Up to 2 years

• Adverse experiences

  Up to 2 years

Study Arms (1)

Treatment (yttrium Y 90 glass microspheres)

EXPERIMENTAL

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.

Radiation: yttrium Y 90 glass microspheres; Other: laboratory biomarker analysis; Drug: TheraSphere

Interventions

yttrium Y 90 glass microspheres RADIATION

Given Interartrial

Also known as: TheraSphere

Treatment (yttrium Y 90 glass microspheres)

laboratory biomarker analysis OTHER

Alpha-fetoprotein assay

Also known as: Correlative studies, AFP

Treatment (yttrium Y 90 glass microspheres)

TheraSphere DRUG

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

Treatment (yttrium Y 90 glass microspheres)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Rikabi Ali, M.D.

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: October 11, 2010
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)