Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022334
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2001-08-10
Brief Title:
Vaccine Therapy in Treating Patients With Liver Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a persons white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A0201-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
Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A0201-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0001026 | None | None | None |
| NCI-G01-1997 | None | None | None |