Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093548
Status:
WITHDRAWN
Last Update Posted:
2012-10-04
First Post:
2004-10-06
Brief Title:
Vaccine Therapy in Treating Patients With Stage II Stage IIIA Stage IIIB or Stage IVA Liver Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Trial Testing Immunization With AFP GM-CSF Plasmid Prime And AFP Adenoviral Vector Boost In Patients With Hepatocellular Carcinoma AFP Prime-Boost Protocol
Status:
WITHDRAWN
Status Verified Date:
2012-10
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 DNA and a gene-modified virus may make the body build an immune response to kill tumor cells Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of liver cancer
PURPOSE This phase III trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage II stage IIIA stage IIIB or stage IVA liver cancer
PURPOSE This phase III trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage II stage IIIA stage IIIB or stage IVA liver cancer
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination comprising alpha fetoprotein AFP plasmid DNA and sargramostim GM-CSF plasmid DNA followed by AFP adenoviral vector boost in patients with HLA-A0201-expressing stage II-IVA hepatocellular carcinoma
Secondary
Determine the optimal biological dose of this regimen as defined by the generation of AFP-specific immunity in these patients
Determine disease-free survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of alpha fetoprotein AFP adenoviral vector boost
Patients receive vaccination comprising AFP plasmid DNA and sargramostim GM-CSF plasmid DNA intramuscularly IM on days 1 30 and 60 in the absence of unacceptable toxicity Patients then receive boost immunization comprising AFP adenoviral vector IM and intradermally on day 90
Cohorts of 3-6 patients receive escalating doses of AFP adenoviral vector boost until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 3 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 3-25 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination comprising alpha fetoprotein AFP plasmid DNA and sargramostim GM-CSF plasmid DNA followed by AFP adenoviral vector boost in patients with HLA-A0201-expressing stage II-IVA hepatocellular carcinoma
Secondary
Determine the optimal biological dose of this regimen as defined by the generation of AFP-specific immunity in these patients
Determine disease-free survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of alpha fetoprotein AFP adenoviral vector boost
Patients receive vaccination comprising AFP plasmid DNA and sargramostim GM-CSF plasmid DNA intramuscularly IM on days 1 30 and 60 in the absence of unacceptable toxicity Patients then receive boost immunization comprising AFP adenoviral vector IM and intradermally on day 90
Cohorts of 3-6 patients receive escalating doses of AFP adenoviral vector boost until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 3 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 3-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0302008-02 | None | None | None |