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Immunotherapy of Stage III/IV Melanoma Patients

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase I

Treatment

Active

18 and over

Other

LUD 2001-003
NCT00112242

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Ludwig Institute for Cancer Research

Olivier Michielin, MD

Principal Investigator

Trial Sites

Switzerland

Lausanne

Centre Hospitalier Universitaire Vaudois

Daniel E. Speiser, MD Ph: +41.21.314.01.82

Email: daniel.speiser@hospvd.ch

E.

Daniel E. Speiser, MD Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00112242
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.