Vaccine Therapy in Treating Patients With Liver Cancer
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma|
- Dose limiting toxicity and maximum tolerable dose. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Generation of AFP specific immunity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression-free survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- clinical response in patients with measurable disease. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2001|
|Study Completion Date:||October 2008|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
See intervention description.
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.
Other Name: AFP peptide-pulsed autologous DC
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022334
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||James S. Economou, MD||Jonsson Comprehensive Cancer Center|