Immunotherapy of Melanoma Patients
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.
Biological: Melan-A analog peptide
Biological: FluMa peptide
Biological: Mage-A10 peptide
Biological: SB AS-2 adjuvant
Biological: Montanide adjuvant
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node|
- 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
- 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
|Study Start Date:||May 1999|
|Study Completion Date:||June 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.
|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|