Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291473
Status:
COMPLETED
Last Update Posted:
2009-03-03
First Post:
2006-02-10
Brief Title:
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 CHP-HER2 and NY-ESO-1 Protein CHP-NY-ESO-1 in Combination With OK-432 in HER2- andor NY-ESO-1-Expressing Cancers
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Mixed cancer vaccines CHP-HER2 protein and CHP-NY-ESO-1 protein are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens Nine patients will be enrolled who are refractory to standard therapies for cancer or at high risk to relapse CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly basis together with OK-432Picibanil as an immunoadjuvant Six doses will be given Toxicity profiles will be monitored and antigen specific humoral anad T cell responses will be described
Detailed Description:
None
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