A pilot trial of hu14.18-IL2 in patients with completely resectable recurrent stage III or stage IV melanoma.

9044 Background: Phase I testing of the hu14.18-IL2 immunocytokine (IC), a mAb reactive with GD2 disialoganglioside, linked to IL2, in patients (pts) with melanoma showed immune activation, reversible toxicities, and a maximal tolerated dose of 7.5 mg/m2/day. Preclinical data in IC-treated tumor bearing mice with low tumor burden documents striking antitumor effects. Thus, we studied IC in melanoma pts in remission but at high risk for recurrence. Methods: Pts with completely resectable recurrent stage III or stage IV melanoma were scheduled to receive 3 cycles of IC at 6 mg/m2/d IV over 4 hours on days 1, 2 and 3 of each 28-day cycle. Pts were randomized to surgical resection of all sites of disease either following (Group A) or prior to (Group B) IC cycle 1. Primary objectives were to evaluate histological evidence of IC anti-tumor activity, time to recurrence, and overall survival (OS). Results: Twenty melanoma pts (11 recurrent stage III, 8 stage IV, one unknown primary) were randomized to Group A (11...