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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of the vaccination will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale

Outcome Time Frame:

Change from baseline at day 372

Safety Issue:

Yes

Principal Investigator

Olivier Michielin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois

Authority:

Switzerland: Swissmedic

Study ID:

LUD 2001-003

NCT ID:

NCT00112242

Start Date:

February 2004

Completion Date:

March 2013

Related Keywords:

  • Melanoma
  • Immunotherapy
  • Vaccination
  • Melanoma
  • Melan-A/Mart-1 peptide
  • MAGE-A10 peptide
  • NY-ESO-1 peptide
  • Montanide
  • Melanoma

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