Mouse monoclonal IgG3 antibody detecting GD3 ganglioside: a phase I trial in patients with malignant melanoma.

Abstract
R24 is an IgG3 mouse monoclonal antibody that identifies GD3, a prominent ganglioside on the surface of melanoma cells and other cells of neuroectodermal origin. Twelve patients with metastatic melanoma were treated with R24 at 3 dose levels, 8, 80 or 240 mg/m2, over a period of 2 wk. Peak antibody levels in the serum were dose related and ranged from < 0.1 to 62 .mu.g/ml. Inflammatory reactions (urticaria, pruritus, erythema, s.c. ecchymoses) were observed around tumor sites in patients treated at doses .gtoreq. 80 mg/m2. Tumor biopsies during and after treatment showed lymphocyte and mast cell infiltration, mast cell degranulation and complement deposition. Side effects were mild and were readily controlled by antihistamines. Major tumor regression has been observed in 3 patients.