Phase I study of fotemustine in pediatric patients with refractory brain tumors.

Background: Fotemustine is a nitrosourea with theoretic and preclinical advantages over the original analogs, carmustine and lomustine, in the treatment of brain tumors. This is the first pediatric Phase I study of fotemustine.

Methods: Patients younger than 21 with recurrent/resistant brain tumors were enrolled in a conventional Phase I study.