Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study

One hundred one patients with advanced pediatric malignant solid tumors, refractory to conventional chemotherapy, were given Novantrone in a Phase II study. A dosage of 18 mg/m2 was administered as a short intravenous infusion every 3 weeks. One complete and 2 partial responses were observed among 26 patients treated for rhabdomyosarcoma; one of 22 patients with neuroblastoma developed a partial response. Nausea and vomiting were uncommon. Leukopenia and/or granulocytopenia developed in 90 of 98 evaluable entries. Two patients developed fatal congestive heart failure, which may have been related to the fact that these patients previously had received doxorubicin; 3 other patients developed evidence of changes in cardiac function, without congestive heart failure. Evidence of activity of this agent in patients who had previously received doxorubicin suggests that Novantrone should be evaluated in pediatric subjects with malignant solid tumors who have had no prior exposure to anthracyclines.