title: A phase I study of human/mouse chimeric antiganglioside GD2 antibody ch14.18 in patients with neuroblastoma.
abstract: 9 patients with stage IV neuroblastoma were treated with 19 courses of human/mouse chimeric monoclonal antiganglioside GD2 antibody ch14.18 at dose levels of 30, 40 and 50 mg/m2/day for 5 days per course. The maximum tolerated dose (MTD) per injection was 50 mg/m2/day. 7 patients received more than one course of treatment, and none revealed any human anti-mouse antibody (HAMA) response. Clinical side-effects of patients treated with ch14.18 were abdominal and joint pains, pruritus and urticaria. One patient presented with a transient pupillatonia, while 2 others showed a unilateral atrophy of the optical nerve that was probably attributable to prior therapies. A complete remission was seen in 2 patients, partial remission in 2 patients, a minor response in 1 patient and stable disease in 1 patient. 3 patients showed tumour progression. Thus, our results indicate that treatment with chimeric MAb ch14.18 can elicit some complete and partial tumour responses in neuroblastoma patients.
authors.affiliation: Department of Paediatric Haematology, Children's Hospital, Tübingen, F.R.G.
authors.forename: R
authors.initials: R
authors.lastname: Handgretinger
authors.forename: K
authors.initials: K
authors.lastname: Anderson
authors.forename: P
authors.initials: P
authors.lastname: Lang
authors.forename: R
authors.initials: R
authors.lastname: Dopfer
authors.forename: T
authors.initials: T
authors.lastname: Klingebiel
authors.forename: M
authors.initials: M
authors.lastname: Schrappe
authors.forename: P
authors.initials: P
authors.lastname: Reuland
authors.forename: S D
authors.initials: SD
authors.lastname: Gillies
authors.forename: R A
authors.initials: RA
authors.lastname: Reisfeld
authors.forename: D
authors.initials: D
authors.lastname: Neithammer
mesh_terms: D019797:3-Iodobenzylguanidine; D000818:Animals; D000911:Antibodies, Monoclonal / Q000097:blood / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005732:Gangliosides / Q000276:immunology*; D006461:Hemolysis; D006801:Humans; D007457:Iodine Radioisotopes; D007462:Iodobenzenes; D008297:Male; D051379:Mice; D009447:Neuroblastoma / Q000097:blood / Q000000981:diagnostic imaging / Q000628:therapy*; D011877:Radionuclide Imaging
chemical_list: D000911:Antibodies, Monoclonal; D005732:Gangliosides; D007457:Iodine Radioisotopes; D007462:Iodobenzenes; D019797:3-Iodobenzylguanidine; C019403:ganglioside, GD2