Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma

Wim H.J. Kruit, Heidi H. Van Ojik, Vincent G. Brichard, Bernard Escudier, Thierry Dorval, Brigitte Dréno, Poulam Patel, Nicolas Van Baren, Marie Françoise Avril, Sophie Piperno, Amir Khammari, Marguerite Stas, Gerd Ritter, Bernard Lethé, Danièle Godelaine, Francis Brasseur, Yi Zhang, Pierre Van Der Bruggen, Thierry Boon, Alexander M.M. EggermontMarie Marchand

Onderzoeksoutput: Bijdrage aan tijdschriftArtikelpeer review

144 Citaten (Scopus)

Samenvatting

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 Axed 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.

Originele taal-2Engels
Pagina's (van-tot)596-604
Aantal pagina's9
TijdschriftInternational Journal of Cancer
Volume117
Nummer van het tijdschrift4
DOI's
StatusGepubliceerd - 20 nov. 2005
Extern gepubliceerdJa

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