Phase I clinical and pharmacokinetic study of bisantrene in refractory pediatric solid tumors.

摘要: Fourteen patients with pediatric malignant solid tumors, median age 15 years, received 22 courses of bisantrene in a Phase I study. Dosage escalations ranged from 10 to 120 mg/m2 daily for 5 consecutive days. Toxicity included myelosuppression and phlebitis. A sensitive (detection limit 2 ng/ml) specific HPLC method was developed quantitate patient's plasma urine. Peak concentrations at the end 60 minute infusions 568 ng/ml 6800 100 dosage. The elimination half life (T 1/2β) averaged about hours but increased 20 patient liver disease. Only 2.4–10% dose eliminated urine suggesting that may be major route this antineoplastic anthracene derivative.