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.
- 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
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
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.
- 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.
- 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
- HIV-infected patients.
- Patients with any underlying conditions which would contraindicate therapy with study
- Patients with organ allografts.
- O2 sat <91% on room air; dyspnea at rest.