Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

Allan Tsung

Status and phase: Withdrawn; Phase 2

Conditions: Liver Cancer

Treatments: Radiation: yttrium Y 90 glass microspheres

Study type: Interventional

Funder types: Other

Identifiers

NCT00039078

PCI-IRB-000871

CDR0000069336 (Registry Identifier)

PCI-IRB-0611014

PCI-IRB-000656

NCI-V02-1701

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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