Immunotherapy of Melanoma Patients
Specific Immunotherapy of Skin Melanoma Patients With Antigenic Peptides and Immunological Analysis of the Vaccine Site Sentinel Lymph Node
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 1999
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1999
CompletedFirst Submitted
Initial submission to the registry
May 31, 2005
CompletedFirst Posted
Study publicly available on registry
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedApril 24, 2013
March 1, 2009
8.1 years
May 31, 2005
April 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (1)
Ayyoub M, Zippelius A, Pittet MJ, Rimoldi D, Valmori D, Cerottini JC, Romero P, Lejeune F, Lienard D, Speiser DE. Activation of human melanoma reactive CD8+ T cells by vaccination with an immunogenic peptide analog derived from Melan-A/melanoma antigen recognized by T cells-1. Clin Cancer Res. 2003 Feb;9(2):669-77.
PMID: 12576434RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Speiser, MD
Ludwig Institute for Cancer Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 31, 2005
First Posted
June 1, 2005
Study Start
May 1, 1999
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
April 24, 2013
Record last verified: 2009-03