Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients - Full Text View

Sponsored by:	Ludwig Institute for Cancer Research
Information provided by:	Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:	NCT00112229

Purpose

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.

Condition	Intervention	Phase
Melanoma	Biological: Melan-A natural peptide Biological: Melan-A analog peptide Biological: Tyrosinase peptide Biological: Montanide ISA-51 adjuvant Biological: CpG 7909 oligonucleotides adjuvant	Phase I

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Tyrosinase Montanide ISA 51

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients With CpG7909, Tumor Antigenic Peptides and Montanide

Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:

Melan-A and Tyrosinase specific CD8+ T-cell reactivity will be measured by Tetramers and Elispot assays [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
Safety of vaccination will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI CTC) scale [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

In patients with measurable disease, tumor response will be assessed radiologically [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	29
Study Start Date:	April 2003
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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

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 +/- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112229

Locations

Switzerland, Vaud
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011

Sponsors and Collaborators

Ludwig Institute for Cancer Research

Investigators

Principal Investigator:

Olivier Michielin, MD

Ludwig Institute for Cancer Research

More Information

Publications of Results:

Speiser DE, Lienard D, Rufer N, Rubio-Godoy V, Rimoldi D, Lejeune F, Krieg AM, Cerottini JC, Romero P. Rapid and strong human CD8+ T cell responses to vaccination with peptide, IFA, and CpG oligodeoxynucleotide 7909. J Clin Invest. 2005 Mar;115(3):739-46.

Responsible Party:	Ludwig Institute for Cancer Research ( Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs )
Study ID Numbers:	LUD 2000-018
Study First Received:	May 31, 2005
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00112229
Health Authority:	Switzerland: Swissmedic

Keywords provided by Ludwig Institute for Cancer Research:

Immunotherapy
Vaccination
Melanoma
Melan-A/Mart-1 peptide

Tyrosinase peptide
CpG
Montanide

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009