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Immunotherapy of Stage III/IV Melanoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00112242
Recruitment Status : Completed
First Posted : June 1, 2005
Last Update Posted : April 22, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

May 31, 2005
June 1, 2005
April 22, 2013
February 2004
March 2013   (Final data collection date for primary outcome measure)
  • Safety of the vaccination will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale [ Time Frame: Change from baseline at day 372 ]
  • Immune response induced by vaccination with melanoma antigen peptides will be determined [ Time Frame: Change from baseline in CD8 T-cells reactivity at day 372 ]
  • Melan-A, Mage-10 and NY-ESO specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays
  • Safety of the vaccination will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
Complete list of historical versions of study NCT00112242 on ClinicalTrials.gov Archive Site
In patients with measurable disease, tumor response will be assessed by radiology [ Time Frame: Change from baseline in tumor response at day 372 ]
In patients with measurable disease, tumor response will be assessed by radiology
Not Provided
Not Provided
 
Immunotherapy of Stage III/IV Melanoma Patients
Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides [Melan-A/Mart-1 Analog (ELA), NY-ESO-1b(A) Analog and MAGE-A10] and Montanide Adjuvant
The purpose of this study is to determine whether vaccination with melanoma antigen peptides [Melan-A/Mart-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.

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-A10,long 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
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma
  • Biological: Montanide + Melan-A analogue peptide
    1 ml Montanide+ 500 mcg Melan-A analog peptide
  • Biological: Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
    1 ml Montanide + 500 mcg Melan-A analog peptide + 500 mcg NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
  • Biological: Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
    1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 500 mcg Melan-A analog peptide, 500 mcg + NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
  • Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
    1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide
  • Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2
    1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide + low dose IL-2
  • Experimental: 1
    Montanide + Melan-A analogue peptide
    Intervention: Biological: Montanide + Melan-A analogue peptide
  • Experimental: 2
    Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
    Intervention: Biological: Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
  • Experimental: 3
    Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
    Intervention: Biological: Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
  • Experimental: 4
    Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
    Intervention: Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
  • Experimental: 5
    Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2
    Intervention: Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed stage III or stage IV melanoma
  • Tumor expression of Melan-A +/- one of the tumor antigens MAGE-A10, NY-ESO-1, or LAGE-1
  • Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

  • Clinically significant heart disease
  • Serious illnesses, eg, serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders
  • History of immunodeficiency disease or autoimmune disease
  • Coagulation or bleeding disorders
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00112242
LUD 2001-003
No
Not Provided
Not Provided
Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Ludwig Institute for Cancer Research
Principal Investigator: Olivier Michielin, MD Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP