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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 31, 2005

Last Updated Date

April 19, 2013

Start Date ^ICMJE

February 2004

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Safety of the vaccination will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
Melan-A, Mage-10 and NY-ESO specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays

Change History

Complete list of historical versions of study NCT00112242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

In patients with measurable disease, tumor response will be assessed by radiology

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immunotherapy of Stage III/IV Melanoma Patients

Official Title ^ICMJE

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

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00112242

Other Study ID Numbers ^ICMJE

LUD 2001-003

Has Data Monitoring Committee

Responsible Party

Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire Vaudois

Collaborators ^ICMJE

Ludwig Institute for Cancer Research

Investigators ^ICMJE

Principal Investigator:

Olivier Michielin, MD

Centre Hospitalier Universitaire Vaudois

Information Provided By

Centre Hospitalier Universitaire Vaudois

Verification Date

April 2013

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

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