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Immunotherapy of Stage III/IV Melanoma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00112242
First Posted: June 1, 2005
Last Update Posted: April 22, 2013
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.
Collaborator:
Ludwig Institute for Cancer Research
Information provided by (Responsible Party):
Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
  Purpose
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.

Condition Intervention Phase
Melanoma Biological: Montanide + Melan-A analogue peptide Biological: Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide Biological: Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide Biological: Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + 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 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • In patients with measurable disease, tumor response will be assessed by radiology [ Time Frame: Change from baseline in tumor response at day 372 ]

Enrollment: 38
Study Start Date: February 2004
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montanide + Melan-A analogue peptide
Biological: Montanide + Melan-A analogue peptide
1 ml Montanide+ 500 mcg Melan-A analog peptide
Experimental: 2
Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 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
Experimental: 3
Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + 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
Experimental: 4
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + 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
Experimental: 5
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2
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

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-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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112242


Locations
Switzerland
Oncology Department, University Hospital Lausanne
Lausanne, Vaud, Switzerland, 1011
Division of Oncology at the Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Ludwig Institute for Cancer Research
Investigators
Principal Investigator: Olivier Michielin, MD Centre Hospitalier Universitaire Vaudois
  More Information

Publications:
Responsible Party: Prof Olivier Michielin, M.D., Ph.D., Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT00112242     History of Changes
Other Study ID Numbers: LUD 2001-003
First Submitted: May 31, 2005
First Posted: June 1, 2005
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois:
Immunotherapy
Vaccination
Melanoma
Melan-A/Mart-1 peptide
MAGE-A10 peptide
NY-ESO-1 peptide
Montanide

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas