Phase II evaluation of diglycoaldehyde (Inox) in children with acute leukemia: a children's cancer study group report.
A phase I trial of diglycoaldehyde (Inox) in children with leukemia established that the maximum tolerated dose of a 5-day schedule was 1.5 g/m2/day. A phase II study was undertaken by the Children's Cancer Study Group to evaluate the efficacy of this dose. Forty-seven children with acute leukemia refractory to conventional forms of therapy were entered in the study: 29 patients with acute lymphocyte leukemia/acute undifferentiated leukemia and 18 with acute nonlymphocytic leukemia. Inox was administered at a dose of 1.5 g/m2 as a 4-6 hour iv infusion daily for 5 days every 14 days. Toxic effects included myelosuppression, proteinuria, nausea, vomiting, diarrhea, local tissue reactions, hypocalcemia, transitory serum amylase elevation, and transitory hypotension. There was one life-threatening episode of drug-related renal toxicity. Of the 27 patients who received a minimum of two courses, partial remissions were observed in two patients with acute nonlymphocytic leukemia. Inox was inactive against advanced acute lymphocytic leukemia.
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000447:Aldehydes / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007288:Inosine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007674:Kidney Diseases / Q000139:chemically induced; D007938:Leukemia / Q000188:drug therapy*; D008297:Male
D000447:Aldehydes; D000970:Antineoplastic Agents; C007390:inosine dialdehyde; D007288:Inosine