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

Liver Cancer Clinical Trial

Official title:

A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530010
• Other study ID #: NU 1365-001
• Secondary ID: P30CA060553NU-13
• Status: Completed
• Start date: December 2004
• Est. completion date: March 8, 2022

Study information

• Verified date: August 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

• Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection.

• Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. 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 at 2 weeks, 30 days, and then once a year for approximately 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of intrahepatic carcinoma

• Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP

• Unresectable disease

• No portal hypertension with portal venous shunt away from the liver

• No significant extrahepatic disease representing an imminent life-threatening outcome

• No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:

• First yttrium Y 90 glass microspheres (TheraSphere®) administration

• Cumulative delivery of radiation to the lungs over multiple treatments

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-2

• Absolute granulocyte count = 1,500/µL

• Platelet count > 25,000/µL

• Serum creatinine < 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)

• Serum bilirubin = 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

Exclusion criteria:

• Any of the following contraindications to angiography and selective visceral catheterization:

• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques

• Bleeding diathesis, not correctable by usual forms of therapy

• Severe peripheral vascular disease that would preclude catheterization

• Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow

• Severe liver dysfunction or pulmonary insufficiency

• Active uncontrolled infection

• Significant underlying medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior and no other concurrent anticancer therapy

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Radiation:
• yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, Atassi B, Baker T, Gates V, Miller FH, Sato KT, Wang E, Gupta R, Benson AB, Newman SB, Omary RA, Abecassis M, Kulik L. Radioembolization for hepatocellular carcinoma using Yttrium-90 microsph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Completion	Proportion of patients completing scheduled treatment plan	Through study completion, up to 24 months or when patient discontinues treatment for whatever reason.