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Phase I evaluation of diaziquone in childhood cancer
Authors:J. M. Falletta  B. Cushing  S. Lauer  B. Bell  D. H. Mahoney  R. Castleberry  R. A. Krance
Affiliation:(1) Duke University Medical Center, Durham, NC, USA;(2) Children's Hospital of Michigan, Detroit, MI, USA;(3) Medical College of Wisconsin, Milwaukee, WI, USA;(4) Emory University School of Medicine, Atlanta, GA, USA;(5) Baylor College of Medicine, Houston, TX, USA;(6) University of Alabama School of Medicine, Birmingham, AL, USA;(7) City of Hope National Medical Center, Duarte, CA, USA;(8) (8136/38) Pediatric Oncology Group, Operations Office, Suite 2A, 4949 West Pine Boulevard, 63108-1498 St. Louis, MO, USA
Abstract:Summary We conducted a phase I clinical study of aziridinylbenzoquinone (Diaziquone, AZQ) given as a 4 hour infusion weekly × 4. Forty-five children with recurrent acute leukemia and 33 children with various advanced solid tumors participated. Severe myelosuppression was the dose limiting toxic effect, occurring in all patients at the upper dose levels. Gastrointestinal and hepatic toxicities were infrequent and not severe. No allergic reactions occurred. Objective tumor regression was noted in 3 of 25 patients with a CNS tumor and in 6 of 45 patients with acute leukemia. For phase II trials the recommended dosage of Diaziquone given by this schedule is 18 mg/M2×4 for patients with a solid tumor, and is 30 mg/M2/week × 4 for children with acute leukemia.
Keywords:diaziquone  childhood malignancies  chemotherapy
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