A phase I study of human/mouse chimeric antiganglioside GD2 antibody ch14.18 in patients with neuroblastoma

Eur J Cancer. 1995;31A(2):261-7. doi: 10.1016/0959-8049(94)00413-y.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • 3-Iodobenzylguanidine
  • Animals
  • Antibodies, Monoclonal / blood
  • Antibodies, Monoclonal / therapeutic use*
  • Child
  • Child, Preschool
  • Female
  • Gangliosides / immunology*
  • Hemolysis
  • Humans
  • Iodine Radioisotopes
  • Iodobenzenes
  • Male
  • Mice
  • Neuroblastoma / blood
  • Neuroblastoma / diagnostic imaging
  • Neuroblastoma / therapy*
  • Radionuclide Imaging

Substances

  • Antibodies, Monoclonal
  • Gangliosides
  • Iodine Radioisotopes
  • Iodobenzenes
  • 3-Iodobenzylguanidine
  • ganglioside, GD2