PHASE-II STUDY OF AMONAFIDE IN PATIENTS WITH RECURRENT GLIOMA

Amonafide, a novel imide derivative with broad preclinical antitumor a ctivity, achieves significant cerebrospinal fluid levels in animal mod els. In order to test its antitumor activity in patients with recurren t diffuse infiltrative glioma of the astrocytic and oligodendroglial t ype, we performed a phase II clinical trial. Of the 22 eligible and ev aluable patients treated, 2 (9%) experienced tumor regression lasting more than one year. No other patients experienced tumor regression; on e remained stable more than six months. Toxicities consisted primarily of myelosuppression, vomiting, and venous irritation at the infusion site. We conclude that amonafide has minimal activity in recurrent gli oma patients. Further investigations are not warranted in this study p opulation.