Vaccine Therapy in Treating Patients With Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00022334|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Biological: AFP||Phase 1 Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||October 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|