Title: Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma
Authors: Kruit, Wim H J ×
van Ojik, Heidi H
Brichard, Vincent G
Escudier, Bernard
Dorval, Thierry
Dréno, Brigitte
Patel, Poulam
van Baren, Nicolas
Avril, Marie-Françoise
Piperno, Sophie
Khammari, Amir
Stas, Marguerite
Ritter, Gerd
Lethé, Bernard
Godelaine, Danièle
Brasseur, Francis
Zhang, Yi
van der Bruggen, Pierre
Boon, Thierry
Eggermont, Alexander M M
Marchand, Marie #
Issue Date: Nov-2005
Series Title: International Journal of Cancer vol:117 issue:4 pages:596-604
Abstract: The purpose of this phase 1/2 study was to evaluate toxicity, tumor evolution and immunologic response following administration of a fixed dose of a recombinant MAGE-3 protein by subcutaneous and intradermal routes in the absence of immunologic adjuvant. Thirty-two patients with detectable metastatic melanoma expressing gene MAGE-3 were included and 30 received at least one injection with a fixed dose of a ProtD-MAGE-3 fusion protein. The immunization schedule included 6 intradermal and subcutaneous injections at 3-week intervals. Afterward, patients without major tumor progression who required other treatments received additional vaccinations at increasing time intervals. The vaccine was generally well tolerated. Among the 26 patients who received at least 4 vaccinations, we observed 1 partial response and 4 mixed responses. For these 5 responding patients, time to progression varied from 3.5 to 51+ months. An anti-MAGE-3 CD4 T-lymphocyte response was detected in 1 out of the 5 responding patients. The majority of patients had no anti-MAGE-3 antibody response. The clinical and immunologic responses generated by the vaccine are rather limited. Nevertheless, given the potential antitumor efficacy and the very mild toxicity of vaccinations, further studies combining MAGE proteins and/or peptides with potent immunologic adjuvants are warranted, not only in metastatic melanoma, but also in the adjuvant setting.
ISSN: 0020-7136
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Surgical Oncology
× corresponding author
# (joint) last author

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