Immunotherapy of Stage III/IV Melanoma Patients - Full Text View

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:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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:

Speiser DE, Pittet MJ, Rimoldi D, Guillaume P, Luescher IF, Lienard D, Lejeune F, Cerottini JC, Romero P. Evaluation of melanoma vaccines with molecularly defined antigens by ex vivo monitoring of tumor-specific T cells. Semin Cancer Biol. 2003 Dec;13(6):461-72. Review.

Lienard D, Rimoldi D, Marchand M, Dietrich PY, van Baren N, Geldhof C, Batard P, Guillaume P, Ayyoub M, Pittet MJ, Zippelius A, Fleischhauer K, Lejeune F, Cerottini JC, Romero P, Speiser DE. Ex vivo detectable activation of Melan-A-specific T cells correlating with inflammatory skin reactions in melanoma patients vaccinated with peptides in IFA. Cancer Immun. 2004 May 19;4:4.

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 May 21, 2013