RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Internal radiation uses radioactive material placed directly into the tumor to kill tumor cells and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of combining hepatic arterial infusion with internal radiation therapy in treating patients who have liver cancer that can not be removed by surgery.

Condition	Treatment or Intervention	Phase
localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma	Drug: yttrium Y 90 glass microspheres  Procedure: brachytherapy  Procedure: embolization therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium Y 90 glass microspheres (TheraSphere).
• 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: Patients receive yttrium Y 90 glass microspheres (TheraSphere) via hepatic arterial infusion using the TheraSphere administration set on day 1. Courses repeat every 2-4 months (until all tumor in the liver has been treated) in the absence of disease progression, unacceptable toxicity, or a cumulative lung dose of more than 30 Gy.

Quality of life is assessed at baseline, monthly for 3 months, and then every 3 months for 9 months.

Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 4 months for 1 year.

PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed unresectable primary hepatocellular carcinoma (HCC)
• Histopathologic confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for HCC, and an alpha-fetoprotein level greater than 1,000 ng/mL
• Known extrahepatic disease limited to lymph nodes of less than 2 cm
• Measurable or evaluable disease by CT scan or MRI

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 60,000/mm^3
• No bleeding diathesis not correctable by usual forms of therapy

Hepatic:

• See Disease Characteristics
• Bilirubin no greater than 3.0 mg/dL
• No portal vein thrombosis
• No portal hypertension with hepatofugal flow
• No severe liver dysfunction

Renal:

• Creatinine no greater than 2.0 mg/dL
• No renal insufficiency

Cardiovascular:

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

Pulmonary:

• No pulmonary insufficiency

Other:

• 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 Y 90 glass microspheres (TheraSphere) administration or with cumulative delivery of radiation to the lungs over multiple treatments
• 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 allergy to contrast dye
• No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other condition that would preclude study
• 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: Biologic therapy:

• No more than 1 prior immunotherapy treatment for HCC

Chemotherapy:

• At least 1 month since prior chemotherapy
• No more than 1 prior chemoembolization treatment for HCC
• No more than 1 prior systemic chemotherapy regimen for HCC

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior external hepatic radiotherapy for HCC

Surgery:

• See Disease Characteristics
• At least 1 month since prior surgery

Other:

• No prior intra-arterial treatment for HCC
• No other concurrent investigational agents or anticancer therapy for HCC

Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study chairs or principal investigators

Brian I. Carr, MD,  Study Chair,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  CDR0000069336; PCI-IRB-000656; PCI-IRB-000871; NCI-V02-1701; NCT00039078
Record last reviewed:  June 2002
Last Updated:  December 3, 2004
Record first received:  June 6, 2002
ClinicalTrials.gov Identifier:  NCT00039078
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08