Phase I clinical trial on adjuvant active immunotherapy of human gliomas with GD2-conjugate.
The objective of this study was to determine the feasibility, toxicity, and potential therapeutic benefits of an adjuvant active immunotherapy using a tumour specific ganglioside (GD2) conjugate for the adjuvant treatment of recurrent or progressive gliomas. Seven patients with proven GD2 expression in surgical specimens underwent a vaccination course with GD2-KLH/MPL-A conjugate. The follow-up was performed according to WHO guidelines regarding common toxicity criteria. Antibody titres against the ganglioside and the adjuvants were analysed. All patients developed a local type 4 reaction. Anti-GD2-antibody titres could not be detected, despite high titres against the immunoadjuvants. No tumour regression was observed. The disease remained stable for a median of 21.5 weeks (6-34 weeks). The median survival time after the first immunization was 47 weeks. The medial total survival time was 76 weeks. Adverse effects have not been observed. Active GD2-KLH/MPL-A immunization was technically feasible, but did not elicit anti-GD2 antibody generation.
becker5@mailer.uni-marburg.de
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Becker
M K
MK
Eichler
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Jennemann
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Bertalanffy
D000276:Adjuvants, Immunologic; D000328:Adult; D000368:Aged; D000818:Animals; D001932:Brain Neoplasms / Q000000981:diagnostic imaging / Q000628:therapy*; D004797:Enzyme-Linked Immunosorbent Assay; D005240:Feasibility Studies; D005260:Female; D005732:Gangliosides / Q000627:therapeutic use*; D005910:Glioma / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D007075:Immunoglobulin M / Q000032:analysis; D016233:Immunotherapy, Active / Q000379:methods*; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011859:Radiography; D014611:Vaccination / Q000379:methods
D000276:Adjuvants, Immunologic; D005732:Gangliosides; D007074:Immunoglobulin G; D007075:Immunoglobulin M; C019403:ganglioside, GD2