Immunotherapy of Melanoma Patients - Full Text View

Sponsored by:	Ludwig Institute for Cancer Research
Information provided by:	Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:	NCT00112216

Purpose

The purpose of this study is to test whether vaccination with antigenic peptides induces an immune response in the vaccine site sentinel lymph node of patients with microscopically detectable lymph node melanoma metastases.

Condition	Intervention	Phase
Melanoma	Biological: Melan-A analog peptide Biological: FluMa peptide Biological: Mage-A10 peptide Biological: SB AS-2 adjuvant Biological: Montanide adjuvant	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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

Primary Outcome Measures:

Melan-A, Flu and Mage specific CD8+ T-cell reactivity obtained from different body sites (vaccine site draining lymph node, other lymph node) will be measured by Tetramers and Elispot assays

Secondary Outcome Measures:

Safety and toxicity of antigenic peptides administered with high dose adjuvant will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale

Estimated Enrollment:	9
Study Start Date:	May 1999
Estimated Study Completion Date:	April 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

The study is designed for patients with skin melanoma and lymph node micrometastasis previously diagnosed by a sentinel node procedure. As a result of their diagnosis, the patients are scheduled for lymph node dissection.

Before this is done, patients are vaccinated with antigenic peptides. The peptides are mixed with the adjuvant SB AS-2 or Montanide and injected in a lower limb not affected by the disease. The skin site of vaccine injection is marked with a permanent pen where, two weeks later, patent blue and 99technetium is injected. These markers allow one to locate the vaccine site sentinel node (VSSN) which will be removed during the lymph node dissection at the diseased limb. The aim of the study is to test whether the vaccine has induced an immune response in the lymph node that drains the vaccine site.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with microscopically detectable lymph node metastases
Positive detection of the Melan-A gene +/- MAGE-10 in positive sentinel node or primary tumor tissue by polymerase chain reaction (PCR) analysis of mRNA and/or by immunohistochemistry using monoclonal antibodies
Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

Previous splenectomy or radiotherapy to the spleen
Treatment with systemic antihistamines, corticosteroids, or non-steroidal anti-inflammatory drugs (except occasional or low dose non-steroidal anti-inflammatory drugs such as 100 mg aspirin/day) within 4 weeks of entry into the study
Heart disease (New York Heart Association [NYHA] Class III or IV)
Serious illness, e.g. active infections requiring antibiotics, bleeding disorders or other diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112216

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:

Daniel Speiser, MD

Ludwig Institute for Cancer Research

More Information

Publications:

Ayyoub M, Zippelius A, Pittet MJ, Rimoldi D, Valmori D, Cerottini JC, Romero P, Lejeune F, Lienard D, Speiser DE. Activation of human melanoma reactive CD8+ T cells by vaccination with an immunogenic peptide analog derived from Melan-A/melanoma antigen recognized by T cells-1. Clin Cancer Res. 2003 Feb;9(2):669-77.

Responsible Party:	Ludwig Institute for Cancer Research ( Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs )
Study ID Numbers:	LUD 1998-009
Study First Received:	May 31, 2005
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00112216 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by Ludwig Institute for Cancer Research:

Immunotherapy
Vaccination
Melanoma
Melan-A/Mart-1 peptide

Flu peptide
Mage-A10 peptide
SB AS-2 adjuvant
Montanide adjuvant

Study placed in the following topic categories:

Neuroectodermal Tumors
Immunologic Factors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Adjuvants, Immunologic
Influenza, Human

Neuroepithelioma
Nevus
Melanoma, Familial
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Germ Cell and Embryonal
Physiological Effects of Drugs

Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Nevi and Melanomas
Pharmacologic Actions
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on August 30, 2009