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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Increasing doses of AFP will be given to groups of 3 intradermally. Subjects will receive 3 biweekly vaccinations. At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Dose limiting toxicity and maximum tolerable dose.
Time frame: 1 year
Generation of AFP specific immunity.
Time frame: 3 years
Progression-free survival.
Time frame: 3 years
clinical response in patients with measurable disease.
Time frame: 3 years
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