OBJECTIVES:

• Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma.
• Determine the safety and toxicity of this regimen in these patients.
• Determine the immunological effects of this regimen in these patients.
• Determine the progression-free survival and clinical responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.

Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma
• Alpha-fetoprotein level greater than 30 ng/mL
• HLA-A*0201 positive

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin greater than 9.0 g/dL (transfusion independent)
• Platelet count greater than 50,000/mm^3
• Absolute neutrophil count greater than 1,000/mm^3

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No New York Heart Association class III or IV cardiac insufficiency
• No coronary artery disease

Pulmonary:

• Oxygen saturation at least 91% on room air
• No dyspnea at rest

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use 2 methods of effective contraception
• HIV negative
• No prior opportunistic infection
• No congenital or acquired condition causing inability to generate immune response
• Positive response to skin allergens
• No acute viral, bacterial, or fungal infection requiring specific therapy
• No underlying condition that would preclude study participation
• No allergies to reagents used in study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 30 days since prior chemotherapy
• No concurrent cytotoxic chemotherapy

Endocrine therapy:

• At least 30 days since prior steroid therapy
• No concurrent corticosteroids

Radiotherapy:

• Not specified

Surgery:

• No prior organ allografts

Other:

• At least 14 days since prior therapy for acute infection
• No concurrent cyclosporine
• No concurrent immunosuppressive therapy