Vaccine Therapy in Treating Patients With Liver Cancer

Inclusion Criteria:

• HLA-A*0201 positive adults over the age of 18.
• Have HCC with a serum AFP determination >30ng/ml.
• Both male and female patients may be enrolled.
• Karnofsky Performance Status greater than or equal to 70 percent.
• No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
• No previous evidence of opportunistic infection.

• Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:

  1. Hemoglobin >9.0g/dl
  2. Platelets >50000/mm3
  3. Absolute Neutrophil Count >1,000/mm3
• Child-Pugh Class A or B for chronic liver disease.
• Ability to give informed consent.

Exclusion Criteria:

• Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
• Concomitant steroid therapy or chemotherapy, or any of these other treatments < 30 days before the first vaccination.
• Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).
• Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
• HIV-infected patients.
• Patients with any underlying conditions which would contraindicate therapy with study treatment.
• Patients with organ allografts.
• O2 sat <91% on room air; dyspnea at rest.