Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112242
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2005-05-31
Brief Title:
Immunotherapy of Stage IIIIV Melanoma Patients
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides Melan-AMart-1 Analog ELA NY-ESO-1bA Analog and MAGE-A10 and Montanide Adjuvant
Status:
COMPLETED
Status Verified Date:
2020-06
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 determine whether vaccination with melanoma antigen peptides Melan-AMart-1 both EAA and ELA NY-ESO-1b analog Long NY-ESO-1 LP and MAGE-A10 and Montanide CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination
Detailed Description:
Current peptide vaccines suffer from low efficiency since they induce only weak immune activation We have recently confirmed that in humans the immune response was readily detectable in local lymph nodes while no or only weak activation could be identified in circulating lymphocytes Increased doses of antigen and adjuvant allow a better extension from local to systemic immune responses
Group 1 vaccination with Melan-A analog ELA peptide Montanide
Group 2 vaccination with Melan-A analog ELA NY-ESO-1b analog and MAGE-A10 peptides Montanide
Group 3 vaccination with Melan-A analog both EAA and ELA Mage-A10 NY-ESO-1 peptides Montanide CpG adjuvant
Group 4 vaccination with Melan-A ELA Mage-A10long NY-ESO-1LP peptides Montanide CpG
Group 5 vaccination with Melan-A both EAA and ELA Mage-A10 long NY-ESO-1 LP peptides Montanide CpG low dose rIL-2
Group 1 vaccination with Melan-A analog ELA peptide Montanide
Group 2 vaccination with Melan-A analog ELA NY-ESO-1b analog and MAGE-A10 peptides Montanide
Group 3 vaccination with Melan-A analog both EAA and ELA Mage-A10 NY-ESO-1 peptides Montanide CpG adjuvant
Group 4 vaccination with Melan-A ELA Mage-A10long NY-ESO-1LP peptides Montanide CpG
Group 5 vaccination with Melan-A both EAA and ELA Mage-A10 long NY-ESO-1 LP peptides Montanide CpG low dose rIL-2
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