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Sponsored by: |
Ludwig Institute for Cancer Research |
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Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00112216 |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland, Vaud | |
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois | |
Lausanne, Vaud, Switzerland, 1011 |
Principal Investigator: | Daniel Speiser, MD | Ludwig Institute for Cancer Research |
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 |
Immunotherapy Vaccination Melanoma Melan-A/Mart-1 peptide |
Flu peptide Mage-A10 peptide SB AS-2 adjuvant Montanide adjuvant |
Neuroectodermal Tumors Immunologic Factors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic Influenza, Human |
Neuroepithelioma Nevus Melanoma, Familial Neuroendocrine Tumors Melanoma |
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 |