Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062907
Status:
UNKNOWN
Last Update Posted:
2006-12-06
First Post:
2003-06-17
Brief Title:
Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
Sponsor:
Corixa Corporation
Organization:
Corixa Corporation
Study Overview
Official Title:
Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2004-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer The vaccine regimen will consist of two fixed doses of recombinant DNA pVAXL523S followed by two doses of recombinant adenovirus AdL523S The trial will evaluate the dose escalation of AdL523S through three cohorts of patients
Detailed Description:
The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two doses of pVAXL523S and two doses of AdL523S
The secondary objectives of the study are
To provide initial evidence as to whether CD8 and CD4 T cell responses specific for L523S protein can be elicited by two doses of pVAXL523S followed by two doses of AdL523S
To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two doses of pVAXL523S followed by two doses of AdL523S
To investigate the extent to which dose escalation of AdL523S affects the elicited immune response
The secondary objectives of the study are
To provide initial evidence as to whether CD8 and CD4 T cell responses specific for L523S protein can be elicited by two doses of pVAXL523S followed by two doses of AdL523S
To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two doses of pVAXL523S followed by two doses of AdL523S
To investigate the extent to which dose escalation of AdL523S affects the elicited immune response
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