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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Immunotherapy of HLA-A2 Positive 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 Closed 18 and over Other LUD 2000-018
NCT00112229

Trial Description

Summary

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Further Study Information

Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation. The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.

Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;

Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;

Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;

Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed stage III or stage IV melanoma

Tumor expression of Melan-A +/- Tyrosinase

Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

Clinically significant heart disease

Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure 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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00112229
Information obtained from ClinicalTrials.gov on March 18, 2009

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.