NCT00112229

Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients

Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-A/Mart-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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	group 1	Melan-A analog peptide + CpG + Montanide
BIOLOGICAL	group 2	Melan-A natural peptide + CpG + Montanide
BIOLOGICAL	group 3	Melan-A natural peptide + Tyrosinase YMD peptide + CpG + Montanide
BIOLOGICAL	group 4	Melan-A analog peptide + Tyrosinase YMD peptide + CpG + Montanide

Timeline

• Start date: 2003-04-01
• Primary completion: 2011-08-01
• Completion: 2012-06-01
• First posted: 2005-06-01
• Last updated: 2013-04-22

Locations

1 site across 1 country: Switzerland