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Medientyp: E-Artikel Titel: Phase I study of fotemustine in pediatric patients with refractory brain tumors Beteiligte: Hargrave, Darren R.; Bouffet, Eric; Gammon, Janet; Tariq, Nauman; Grant, Ron M.; Baruchel, Sylvain Erschienen: Wiley, 2002 Erschienen in: Cancer, 95 (2002) 6, Seite 1294-1301 Sprache: Englisch DOI: 10.1002/cncr.10814 ISSN: 0008-543X; 1097-0142 Entstehung: Anmerkungen: Beschreibung: AbstractBACKGROUNDFotemustine 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.METHODSPatients younger than 21 with recurrent/resistant brain tumors were enrolled in a conventional Phase I study. Fotemustine was administered intravenously every 3 weeks at increasing dose levels starting at 100 mg/m2. Toxicity and response data were monitored closely.RESULTSFifteen evaluable patients entered the study and received a total of 45 courses of fotemustine (dose range, 100–175 mg/m2). Myelosuppression was observed, with the dose‐limiting toxicity being Grade 4 neutropenia and thrombocytopenia. Toxicity was delayed and cumulative. The maximum tolerated dose was 150 mg/m2 every 3 weeks. There were three documented radiologic responses (20% of patients) comprising one partial response and two minor responses in patients with a sarcoma, medulloblastoma, and ependymoma, respectively.CONCLUSIONSFotemustine administered at a dose of 150 mg/m2 every 3 weeks is well tolerated in children and has antitumor activity in several brain tumors. This is the first dedicated Phase I study of a single agent nitrosourea in a pediatric population. More comparative studies should be undertaken to define the optimum nitrosourea analog for use in children with brain tumors. Cancer 2002;95:1294–301. © 2002 American Cancer Society.DOI 10.1002/cncr.10814 Zugangsstatus: Freier Zugang