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.

Condition	Treatment or Intervention	Phase
Melanoma	Vaccine: Melan-A natural peptide  Vaccine: Melan-A analog peptide  Vaccine: Tyrosinase peptide  Vaccine: Montanide ISA-51 adjuvant  Vaccine: CpG 7909 oligonucleotides adjuvant	Phase I

Further Study Details: 

Primary Outcomes: Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays; Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
Secondary Outcomes: In patients with measurable disease, tumor response will be assessed radiologically
Expected Total Enrollment:  27

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Histologically confirmed stage III or stage IV melanoma
• Tumor expression of Melan-A +/- Tyrosinase
• Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

• Clinically significant heart disease
• Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
• History of immunodeficiency disease or autoimmune disease
• Coagulation or bleeding disorders

Please refer to this study by ClinicalTrials.gov identifier  NCT00112229

Switzerland, Vaud
      Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois, Lausanne,  Vaud,  1011,  Switzerland; Recruiting

Study chairs or principal investigators

Danielle Liénard, MD,  Principal Investigator,  Ludwig Institute for Cancer Research   

Study ID Numbers:  LUD 2000-018
Record last reviewed:  May 2005
Last Updated:  June 1, 2005
Record first received:  May 31, 2005
ClinicalTrials.gov Identifier:  NCT00112229
Health Authority: Switzerland: Swissmedic (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-06-07