RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.

Condition	Treatment or Intervention	Phase
localized resectable adult primary liver cancer localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma	Drug: AFP gene hepatocellular carcinoma vaccine  Drug: autologous dendritic cells  Procedure: biological response modifier therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase I Phase II

Further Study Details: 

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.

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

Criteria

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

James S. Economou, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068806; UCLA-0001026; NCI-G01-1997; NCT00022334
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022334
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08