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


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). IFNgamma-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.
Pfisterer
J
J
Klinik für Gynäkologie und Geburtshilfe, Campus Kiel, Universitätsklinikum Schleswig-Holstein, Kiel, Germany. jpfisterer@email.uni-kiel.de
du Bois
A
A
Sehouli
J
J
Loibl
S
S
Reinartz
S
S
Reuss
A
A
Canzler
U
U
Belau
A
A
Jackisch
C
C
Kimmig
R
R
Wollschlaeger
K
K
Heilmann
V
V
Hilpert
F
F
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018394:CA-125 Antigen / Q000097:blood / Q000276:immunology; D019496:Cancer Vaccines / Q000627:therapeutic use; D002291:Carcinoma, Papillary / Q000276:immunology / Q000628:therapy; D005260:Female; D006801:Humans; D007111:Immunity, Cellular; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000276:immunology / Q000628:therapy*; D010051:Ovarian Neoplasms / Q000276:immunology / Q000628:therapy*; D010349:Patient Compliance; D010534:Peritoneal Neoplasms / Q000556:secondary / Q000628:therapy; D019444:Vaccines, DNA / Q000009:adverse effects / Q000627:therapeutic use
D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018394:CA-125 Antigen; D019496:Cancer Vaccines; D019444:Vaccines, DNA; C518318:abagovomab