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.
- 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
- 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.
- 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
- 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
- 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
- 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
PRIOR CONCURRENT THERAPY:
- At least 1 month since prior chemotherapy, radiotherapy, or surgery
- No other concurrent investigational agents or anticancer therapy for HCC