Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Conditions
Liver Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: yttrium Y 90 glass microspheres
Type: Radiation
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer - 312-695-1301 - cancertrials@northwestern.edu
Start Date
December 2004
Completion Date
January 2018
Sponsors
Northwestern University
Source
Northwestern University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page