A PHASE-I STUDY OF HUMAN MOUSE CHIMERIC ANTIGANGLIOSIDE GD2 ANTIBODY CH14.18 IN PATIENTS WITH NEUROBLASTOMA

9 patients with stage IV neuroblastoma were treated with 19 courses of human/mouse chimeric monoclonal anti-ganglioside GD2 antibody ch14.18 at dose levels of 30, 40 and 50 mg/m(2)/day for 5 days per course. The maximum tolerated dose (MTD) per injection was 50 mg/m(2)/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.