NCT00112216

Immunotherapy of Melanoma Patients

Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Melan-A analog peptide
BIOLOGICAL	FluMa peptide
BIOLOGICAL	Mage-A10 peptide
BIOLOGICAL	SB AS-2 adjuvant
BIOLOGICAL	Montanide adjuvant

Timeline

• Start date: 1999-05-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2005-06-01
• Last updated: 2013-04-24

Locations

1 site across 1 country: Switzerland