Phase I study of 6-diazo-5-oxo-L-norleucine (DON).
We conducted a phase I study of 6-diazo-5-oxo-L-norleucine given iv on a twice weekly schedule. Twenty-six evaluable patients received 31 courses of the drug. Doses ranged from 100 to 500 mg/m2. Nausea with vomiting was the dose-limiting toxic effect, transient thrombocytopenia was seen frequently, and mucositis occurred in 39% of the patients. No definite therapeutic responses were observed in 18 patients with measurable lesions. The recommended dose for phase II studies is 200-300 mg/m2 iv twice weekly.
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001391:Azo Compounds / Q000008:administration & dosage*; D001853:Bone Marrow / Q000187:drug effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D003980:Diazooxonorleucine / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D014839:Vomiting / Q000139:chemically induced
D000970:Antineoplastic Agents; D001391:Azo Compounds; D003980:Diazooxonorleucine