Immunotherapy of Melanoma Patients

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112216
• Other study ID #: LUD 1998-009
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2005
• Last updated: April 23, 2013
• Start date: May 1999
• Est. completion date: June 2007

Study information

• Verified date: March 2009
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Melan-A analog peptide

• FluMa peptide

• Mage-A10 peptide

• SB AS-2 adjuvant

• Montanide adjuvant

Locations

Country	Name	City	State
Switzerland	Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Ayyoub M, Zippelius A, Pittet MJ, Rimoldi D, Valmori D, Cerottini JC, Romero P, Lejeune F, Liénard D, Speiser DE. Activation of human melanoma reactive CD8+ T cells by vaccination with an immunogenic peptide analog derived from Melan-A/melanoma antigen re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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