Immunization With the MAGE-3.A1 Peptide Mixed With the Adjuvant CpG 7909 in Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00145145|
Recruitment Status : Terminated (Poor Accrual)
First Posted : September 5, 2005
Last Update Posted : August 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Biological: MAGE-3.A1 peptide and CpG 7909||Phase 1 Phase 2|
Patients will be vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 µg) mixed with CpG 7909 (5 mg) will be administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
Tumor staging will be performed before inclusion and at week 13. PBL collections will be performed before starting the treatment, and at weeks 3, 7 and 13. They will provide the T lymphocytes for the immunological analysis.
Additional cycles of immunization will be proposed to patients without tumor progression requiring another treatment. A second cycle of 3 injections at 6-week intervals will be started at week 17 with the same vaccine, followed by a third cycle of 12 injections at 3-month intervals starting at month 11. At any time, progression of the disease necessitating any treatment not allowed during the study, will result in study withdrawal.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Immunization With the MAGE-3.A1 Peptide Mixed With the Immunological Adjuvant CpG 7909 in Patients With Metastatic Melanoma|
|Study Start Date :||January 2005|
|Actual Study Completion Date :||April 2007|
- To determine whether immunization with the MAGE-3.A1 peptide mixed with CpG 7909 results in a detectable cytolytic T cell (CTL) response.
- To analyze the toxicity of these immunizations.
- To determine the clinical effectiveness of these immunizations in the patients with measurable disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145145
|Cliniques Universitaires Saint-Luc (UCL)|
|Brussels, Belgium, B-1200|
|Ludwig Institute for Cancer Research|
|Brussels, Belgium, B-1200|
|Study Chair:||Nicolas van Baren, MD||Ludwig Institute for Cancer Research|
|Study Director:||Thierry Boon, PhD||Ludwig Institute for Cancer Research|