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Brill, T.H.* ; Kübler, H.R.* ; Pohla, H. ; Buchner, A.* ; Fend, F.* ; Schuster, T.* ; van Randenborgh, H.* ; Paul, R.* ; Kummer, T.* ; Plank, C.* ; Eisele, B.* ; Breul, J.* ; Hartung, R.* ; Schendel, D.J. ; Gansbacher, B.*

Therapeutic vaccination with an Interleukon-2-Iinterferon-γ-secreting allogeneic tumor vaccine in patients with progressive castration-resistant prostate cancer - a phase I/II trial.

Hum. Gene Ther. 20, 1-11 (2009)
DOI PMC
Open Access Green möglich sobald Postprint bei der ZB eingereicht worden ist.
Immunotherapy with whole cell cancer vaccines has been tested in various tumor types. This study investigated the safety profile and antitumor activity of an allogeneic prostate carcinoma cell line, LNCaP, expressing recombinant human interleukin-2 and human interferon-gamma. Thirty HLA-A*0201-matched patients with progressive, castration-resistant prostate cancer received four intradermal injections on days 1, 15, 29, and 92, and then every 90 days, as long as no tumor progression occurred. Three patients received a dose level of 7.5 million cells, and 27 patients received 15 million cells per injection. The primary study criteria were safety and the difference in prostate-specific antigen doubling time (PSA-DT), determined in the pretreatment phase (before the start of vaccination) and in the trial treatment phase (during vaccination). No dose-limiting or autoimmune toxicity was seen. During vaccination there was a significant prolongation of the PSA-DT compared with the prevaccination period (prolongation from 63 to 114 days; p < 0.01; intention to treat). In addition, results showed a period of PSA stabilization of at least 12 weeks, together with stable bone scans in 12 of 30 patients, and 3 patients sustained a >50% decrease in PSA versus baseline. The median overall survival time from first vaccination was 32 months (mean value, 34 months). Immune monitoring revealed T cell stimulation in the majority of patients. This vaccine strategy was found to be safe and well tolerated and was accompanied by prolongation of PSA-DT. The results of this trial warrant clinical development of this vaccine.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Sprache englisch
Veröffentlichungsjahr 2009
HGF-Berichtsjahr 2009
ISSN (print) / ISBN 1043-0342
e-ISSN 1557-7422
Zeitschrift Human Gene Therapy. Clinical Development
Quellenangaben Band: 20, Heft: 12, Seiten: 1-11 Artikelnummer: , Supplement: ,
Verlag Mary Ann Liebert
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Molecular Immunology (IMI)
CCG Immune Monitoring (Platform) (IMI-KIM)
POF Topic(s) 30504 - Mechanisms of Genetic and Environmental Influences on Health and Disease
Forschungsfeld(er) Immune Response and Infection
PSP-Element(e) G-501700-001
G-501700-005
G-520400-001
PubMed ID 19671000
DOI 10.1089/hum.2009.101
Scopus ID 74549148318
Erfassungsdatum 2009-11-27
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