Immunotherapy of Melanoma Patients

Phase 1

Completed

• Conditions: Melanoma

• Registration Number: NCT00112216
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2005-05-31
• Study First Submitted QC: 2005-05-31
• Study First Posted: 2005-06-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2009-03
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland