Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106158
Status:
COMPLETED
Last Update Posted:
2010-11-05
First Post:
2005-03-21
Brief Title:
Safety Study of NY-ESO-1 Protein Vaccine to Treat Cancer Expressing NY-ESO-1
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Immunization of Patients With Tumors Expressing NY-ESO-1 or LAGE Antigen With Complex of NY-ESO-1 Protein and Cholesterol-bearing Hydrophobized Pullulan CHP
Status:
COMPLETED
Status Verified Date:
2007-08
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:
The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing hydrophobized pullulan CHP and NY-ESO-1 protein CHP-NY-ESO-1 and describe the NY-ESO-1 specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients with cancer expressing NY-ESO-1
Detailed Description:
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries SEREX using tumor mRNA and autologous serum from an esophageal cancer patient Reverse transcription-polymerase chain reaction RT-PCR analysis showed that NY-ESO-1 displayed the typical expression pattern of CT antigens NY-ESO-1 mRNA was expressed only in testis of normal tissues tested and in various types of cancer including lung cancer breast cancer malignant melanoma and bladder cancer LAGE-1 was identified by the representational difference analysis and revealed to display 84 amino acid homology with NY-ESO-1 In most cases expression of LAGE-1 parallels the expression of NY-ESO-1 Since testis is an immune privileged organ where HLA molecules are not expressed these antigens can be considered tumor-specific
Because of frequent NY-ESO-1 mRNA expression and high immunogenicity in advanced cancer NY-ESO-1 is an attractive target molecule for a cancer vaccine Current therapies against advanced cancer have limited effectiveness The idea of vaccination with NY-ESO-1 protein in cancer patients with tumors expressing NY-ESO-1 mRNA is based on two findings 1 the number of CD8 T cell epitopes identified in NY-ESO-1 molecule are limited to those binding to HLA-A0201 A31 Cw3 and Cw6 These HLA subtypes are carried by a minor Japanese population 2 CD8 T cell responses specific to NY-ESO-1 are polyclonal Protein vaccination may induce immune response more effectively against tumors expressing NY-ESO-1 than peptide immunization
Because of frequent NY-ESO-1 mRNA expression and high immunogenicity in advanced cancer NY-ESO-1 is an attractive target molecule for a cancer vaccine Current therapies against advanced cancer have limited effectiveness The idea of vaccination with NY-ESO-1 protein in cancer patients with tumors expressing NY-ESO-1 mRNA is based on two findings 1 the number of CD8 T cell epitopes identified in NY-ESO-1 molecule are limited to those binding to HLA-A0201 A31 Cw3 and Cw6 These HLA subtypes are carried by a minor Japanese population 2 CD8 T cell responses specific to NY-ESO-1 are polyclonal Protein vaccination may induce immune response more effectively against tumors expressing NY-ESO-1 than peptide immunization
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