Status:
COMPLETED
Immunotherapy of Melanoma Patients
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 no...
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00112216
Start Date
May 1 1999
End Date
June 1 2007
Last Update
April 24 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ludwig Institute for Cancer Research + Multidisciplinary Oncology Center at the Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011