Immunotherapy of Stage III/IV Melanoma Patients

This study has been completed.
Sponsor:
Collaborator:
Ludwig Institute for Cancer Research
Information provided by (Responsible Party):
Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00112242
First received: May 31, 2005
Last updated: April 19, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 31, 2005
Last Updated: April 19, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by 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

ClinicalTrials.gov processed this record on April 15, 2014