Phase I study of L-asparaginase (NSC 109229).
22 patients received intravenously infused L-asparaginase (Escherichia coli) on a protocol for 5 weekly doses. 13 patients received 100 U/kg, 1 patient 500 U/kg, and 8 patients 1,500 U/kg. Only 3 of the 9 patients receiving 500 U/kg or more were able to complete the 5-week protocol. 11 of the 13 patients receiving 100 U/kg were able to complete the 5-week protocol. Significant tumor responses were not seen. CNS toxicity and allergic reactions were observed at high- and low-dose levels. There was no difference as to the degree of protein changes, BUN elevation, or liver function abnormalities at the different dose levels.
D001215:Asparaginase / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D001798:Blood Proteins / Q000032:analysis; D001943:Breast Neoplasms / Q000188:drug therapy; D002277:Carcinoma / Q000188:drug therapy; D002986:Clinical Trials as Topic; D003110:Colonic Neoplasms / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy; D006801:Humans; D007263:Infusions, Parenteral; D008223:Lymphoma / Q000188:drug therapy; D008545:Melanoma / Q000188:drug therapy; D009369:Neoplasms / Q000188:drug therapy*
D001798:Blood Proteins; D001215:Asparaginase