Viewing Study NCT00112229



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Study NCT ID: NCT00112229
Status: COMPLETED
Last Update Posted: 2013-04-22
First Post: 2005-05-31

Brief Title: Immunotherapy of HLA-A2 Positive Stage IIIIV Melanoma Patients
Sponsor: Centre Hospitalier Universitaire Vaudois
Organization: Centre Hospitalier Universitaire Vaudois

Study Overview

Official Title: Immunotherapy of HLA-A2 Positive Stage IIIIV Melanoma Patients With CpG7909 Tumor Antigenic Peptides and Montanide
Status: COMPLETED
Status Verified Date: 2013-04
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 tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination
Detailed Description: Immune therapy with tumor antigenic peptides is generally quite well tolerated However immune activation is often only weak or even undetectable and clinical responses supposedly corresponding to protective immunity are unfortunately infrequent Further progress is required to improve the vaccines with the goal to increase the strength of immune activation

The tumor antigenic peptides Melan-AMart-1 EAA and ELA and Tyrosinase YMD are combined with two drugs in this study both of which are known to enhance immune responses first CpG 7909 oligodeoxynucleotides and second Montanide ISA-51

Group 1 vaccination with Melan-A analog peptide CpG and Montanide adjuvants
Group 2 vaccination with Melan-A natural peptide CpG and Montanide adjuvants
Group 3 vaccination with Melan-A natural and Tyrosinase peptides CpG and Montanide adjuvants
Group 4 vaccination with Melan-A analog and Tyrosinase peptides CpG and Montanide adjuvants

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