Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node
18 Years
N/A
Both
Melanoma
Trial Information
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.
Inclusion Criteria:
- Patients with microscopically detectable lymph node metastases
- Positive detection of the Melan-A gene +/- MAGE-10 in positive sentinel node or
primary tumor tissue by polymerase chain reaction (PCR) analysis of mRNA and/or by
immunohistochemistry using monoclonal antibodies
- Human leukocyte antigen-A2 (HLA-A2) positive
Exclusion Criteria:
- Previous splenectomy or radiotherapy to the spleen
- Treatment with systemic antihistamines, corticosteroids, or non-steroidal
anti-inflammatory drugs (except occasional or low dose non-steroidal
anti-inflammatory drugs such as 100 mg aspirin/day) within 4 weeks of entry into the
study
- Heart disease (New York Heart Association [NYHA] Class III or IV)
- Serious illness, e.g. active infections requiring antibiotics, bleeding disorders or
other diseases considered by the investigator to have potential for interfering with
obtaining accurate results from this study
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Daniel Speiser, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ludwig Institute for Cancer Research
Authority:
Switzerland: Swissmedic
Study ID:
LUD 1998-009
NCT ID:
NCT00112216
Start Date:
May 1999
Completion Date:
June 2007
Related Keywords:
- Melanoma
- Immunotherapy
- Vaccination
- Melanoma
- Melan-A/Mart-1 peptide
- Flu peptide
- Mage-A10 peptide
- SB AS-2 adjuvant
- Montanide adjuvant
- Melanoma
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