ABSTRACT
Seventy-two children with recurrent, progressive, or metastatic lymphomas and other solid tumors, exclusive of primary central nervous system (CNS) tumors, were treated with aziridinylbenzoquinone (AZQ, diaziquone) at 9 mg/m2/day by 30-min intravenous infusion for 5 days every 3 weeks. Fifty-four patients were evaluable for response. Three partial responses occurred, two in patients with recurrent Hodgkin's disease and one in a patient with intraocular retinoblastoma. Sufficient numbers of patients with osteosarcoma, neuroblastoma, and Wilms' tumor were evaluable to demonstrate inactivity of this dosing regimen in these tumor types. Numbers of evaluable patients for other tumor types were insufficient to conclusively demonstrate inactivity. Myelosuppression, which was profound and prolonged, was observed. As administered in this study, AZQ has marginal activity and severe myelotoxicity in children with solid tumors.
Subject(s)
Antineoplastic Agents/therapeutic use , Aziridines/therapeutic use , Benzoquinones/therapeutic use , Neoplasms/drug therapy , Adolescent , Adult , Antineoplastic Agents/adverse effects , Aziridines/adverse effects , Benzoquinones/adverse effects , Bone Marrow Diseases/chemically induced , Child , Child, Preschool , Drug Evaluation , Humans , Infant , Lymphoma/drug therapy , Neoplasm Recurrence, Local/drug therapyABSTRACT
A phase I/II study of bisantrene using a 3-week schedule was undertaken in 171 children with refractory leukemias and solid tumors. The doses ranged from 190 to 430 mg/m2. The maximum tolerated dose for children with solid tumors and acute leukemias was 280 mg/m2 and 360 mg/m2 every 3 weeks, respectively. The dose limiting toxicities were hepatic and hematologic. One patient with ALL achieved a complete remission and partial responses were observed in three patients with soft-tissue sarcomas. The data indicate that bisantrene, at the doses and schedule used in this study, has limited antitumor activity in pretreated children with cancer.
