Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Conditions
Liver Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Primary Purpose: Treatment
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 the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES:

- Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.

- Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.

- Determine the toxic effects and adverse experiences associated with this therapy in these patients.

- Determine the survival time of patients treated with this therapy.

- Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.

- Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.

- Assess the quality of life of patients treated with this therapy.

OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.

Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Confirmed diagnosis of hepatocellular carcinoma (HCC)

- Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level

- No significant extrahepatic disease that may represent an imminent life-threatening outcome

- No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- No hepatic dysfunction

- Bilirubin ≤ 2.0 mg/dL

- No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization

- No pulmonary insufficiency

- No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow

- No contraindications to angiography

- No contraindications to selective visceral catheterization

- No other condition or cormorbidity that would preclude study treatment

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 30 days after study

PRIOR CONCURRENT THERAPY:

- At least 1 month since prior chemotherapy, radiotherapy, or surgery

- No other concurrent investigational agents or anticancer therapy for HCC
Location
UPMC Liver Cancer Center
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - UPMC Liver Cancer Center - 412-692-2001
Start Date
August 2000
Sponsors
University of Pittsburgh
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page