Phase I study of cyclohexylamine and lysine salt of mafosfamide.
Mafosfamide is a new oxazaphosphorine that breaks down spontaneously into 4-hydroxy-cyclophosphamide. A phase I trial with cyclohexylamine and lysine salts of mafosfamide was carried out in 16 patients, using weekly IV perfusion. Dose-limiting toxicities were not hematological, but consisted in the development of severe pain along the vein during administration. A particular mucosal syndrome with sneezing and conjunctivitis was seen only after administration of the lysine salt. The dose of 700 mg/m2 per week represents the maximum tolerated dose with this weekly schedule.
D000328:Adult; D000368:Aged; D001772:Blood Cell Count / Q000187:drug effects; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010146:Pain / Q000139:chemically induced
C037933:Asta Z 7557; D003520:Cyclophosphamide; C047251:mafosfamide-lysine