Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199836
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2005-09-12
Brief Title:
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1
Status:
COMPLETED
Status Verified Date:
2022-10
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:
This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system Peptides are small fragments of protein NY- ESO-1 peptides are normally found in the testis and the placenta They have also been found on various types of cancer cells The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells
Detailed Description:
This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or LAGE-1 antigen Patients will receive NY-ESO-1b peptide mixed with 05 milliliter mL of Montanide ISA-51 and 1 mg of CpG 7909 given every three weeks for four doses by subcutaneous injection There will be a three-week follow-up period after the fourth injection making the cycle 13 weeks long In the absence of toxicity and progressive disease a second cycle will be offered to patients who have received four vaccinations
The primary objective is to evaluate the immune response antibodies CD8 T-cells and DTH and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide in patients with cancer expressing NY-ESO-1 or LAGE-1 The secondary objective is to document tumor responses in patients with evaluable or measurable disease
The primary objective is to evaluate the immune response antibodies CD8 T-cells and DTH and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide in patients with cancer expressing NY-ESO-1 or LAGE-1 The secondary objective is to document tumor responses in patients with evaluable or measurable disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None