Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00022334


Primary Contact:

Principal Investigator
James S. Economou, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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