Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Daniel Speiser, MD
Ludwig Institute for Cancer Research