Phase I study of oral cyclophosphamide and oral topotecan for children with recurrent or refractory solid tumors

The recommended duration of therapy with a daily schedule of both oral cyclophosphamide (50 mg/m2/day) and topotecan (0.8 mg/m2/day) for previously treated pediatric patients with recurrent or refractory solid tumors is 14 consecutive days. The observed dose limiting toxicity (DLT) was reversible neutropenia. This regimen was well tolerated in heavily pretreated patients and demonstrated activity against recurrent pediatric solid tumors.