A Phase 1 interventional study of Melan-A analog peptide and FluMa peptide in Melanoma, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-24.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 1, Interventional, and Treatment
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
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
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois