Abstract
3002 Background: The hu14.18-IL2 fusion protein consists of IL2 linked to a humanized mAb that recognizes the GD2 disialoganglioside expressed on neuroblastoma (NB) cells. Hu14.18-IL2 has preclinical activity in mouse models of NB and melanoma, particularly when given to mice with a smaller tumor burden. Using the dosing and schedule developed in our phase I study, we determined the antitumor activity of hu14.18-IL2 in two strata of patients with recurrent or refractory NB. Methods: Hu14.18-IL2 was given intravenously at a dose of 12 mg/m2/day over 4 hours for three consecutive days every 28 days. Responses were evaluated every 2 cycles for patients with disease measurable by standard radiographical criteria (stratum 1) and for patients with disease evaluable only by MIBG and/or bone marrow histology (stratum 2). In each stratum, a one-stage design was powered to conclude efficacy with 4 or more responders (CR or PR) out of 20. Response was established by independent radiology review as well as bone marro...
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