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Annals of Oncology 2006 17(10):1568-1577; doi:10.1093/annonc/mdl357
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© 2006 European Society for Medical Oncology

phase I and pharmacokinetics

The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR

J Pfisterer1,*, A du Bois2, J Sehouli3, S Loibl4, S Reinartz5, A Reuß6, U Canzler7, A Belau8, C Jackisch5, R Kimmig9, K Wollschlaeger10, V Heilmann11, F Hilpert1 On behalf of the AGO-OVAR

1 Klinik für Gynäkologie und Geburtshilfe, Campus Kiel, Universitätsklinikum Schleswig-Holstein
2 Klinik für Gynäkologie und Gynäkologische Onkologie, HSK Dr. Horst Schmidt Klinik, Wiesbaden
3 Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum, Berlin
4 Klinik für Gynäkologie und Geburtshilfe, Klinikum der J.W. Goethe-Universität, Frankfurt/M
5 Klinik für Gynäkologie, Gyn. Endokrinologie und Onkologie, Universitätsklinikum Giessen und Marburg, Standort Marburg
6 Koordinierungszentrum für Klinische Studien, Philipps-Universität Marburg
7 Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus, Dresden
8 Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Ernst-Moritz-Arndt Universität Greifswald
9 Frauenklinik, Universitätsklinikum Essen
10 Universitätsfrauenklinik, Otto von Guericke Universität Magdeburg
11 Frauenklinik, Universitätsklinikum Ulm, Germany

* Correspondence to: Prof. Dr. med. J. Pfisterer, Klinik für Gynäkologie und Geburtshilfe, Campus Kiel, Universitätsklinikum Schleswig-Holstein, Michaelisstr. 16, D-24105 Kiel, Germany. Tel: +49-431-597-4089; Fax: +49-431-597-4090; E-mail: jpfisterer{at}email.uni-kiel.de

Background: Abagovomab is a murine anti-idiotypic antibody against the antigen CA-125 which has been shown to elicit humoral and cellular immune responses against ovarian cancer (oc).

Patients and methods: This phase I trial included 36 patients with recurrent oc comparing two subcutaneous (s.c.) vaccination schedules: nine (group L) versus six injections (group S), 18 patients in each group. Four injections of 2.0 mg abagovomab were administered every 2 weeks and then two or five additional doses monthly. Primary endpoint was drop-out rate due to toxicity, and the secondary endpoint was analysis of immunological response.

Results: Treatment was completed in eight (44%) and 16 (89%) patients in groups L and S, respectively. Premature termination occurred due to patient withdrawal or disease progression. No treatment-limiting toxicities occurred in either group. The most common toxicity related to the vaccine was grade 1/2 local injection site reaction. Induction of Ab3 was observed in all evaluable patients. There were no differences between the groups with regard to induction of human anti-mouse antibody (P = 0.1006). IFN{gamma}-expressing CA125-specific CD8+ T-cells were significantly more frequent in group L, while there was no significant difference between CD4+ T-cells in the two groups.

Conclusions: Abagovomab s.c. vaccination is safe and well tolerated. The long vaccination schedule tended to be more effective with regard to AB3-induction and cellular cytotoxicity.

Key words: abagovomab, anti-idiotypic antibody, ovarian cancer, phase I trial, recurrence


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