[Early phase II study of PL-AC [N4-palmitoyl-(1-beta-D-arabinofuranosyl) cytosine] on hematopoietic malignancies].
Twenty-one patients with hematopoietic malignancies including 6 previously untreated, 9 pretreated, and in relapse, 5 in complete remission and one in partial remission all were treated with PL-AC. The patients consisted of 12 acute myelocytic leukemias, 4 acute monocytic leukemias, 2 acute lymphocytic leukemias, one erythroleukemia, one malignant lymphoma and one chronic monocytic leukemia. PL-AC was given orally at a dosage of 50-1200 mg daily. Mean total dosage was 4.74 g (0.6-15.25), and the mean administration period was 3.43 days (1-122). days Responses were observed in 4 out of 9 pretreated patients by a decrease of blast cells in the peripheral blood. Partial remission was obtained in one case which lasted 8 months. Out of 5 previously untreated acute leukemias, one partial remission and 4 hematological responses were observed. The plasma concentration of Ara-C was maximal at 3 hours and was not detectable after 12 hours. Side effects observed were nausea in 5 patients vomiting in one patient and liver dysfunction in one patient. These side effects however were not so severe as to stop drug administration. PL-AC may be administered in doses ranged 150-250 mg for 2-3 weeks without any severe side effects, and with some clinical effects.
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000378:metabolism / Q000627:therapeutic use; D002648:Child; D003561:Cytarabine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000378:metabolism / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007948:Leukemia, Monocytic, Acute / Q000188:drug therapy*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D000970:Antineoplastic Agents; D003561:Cytarabine; C008758:5'-palmitoyl cytarabine