A PHASE-II STUDY OF CARBOPLATIN AS A TREATMENT FOR CHILDREN WITH ACUTE-LEUKEMIA RECURRING IN BONE-MARROW - A REPORT OF THE CHILDRENS CANCERGROUP

BACKGROUND. Carboplatin is an analogue of cisplatin with less nonhemat ologic toxicity and a similar spectrum of antineoplastic activity. Alt hough cisplatin has not been found to be an active agent against leuke mia, carboplatin-induced complete remissions have been observed in adu lts with acute myelogenous leukemia (AML), and antileukemic activity h as been observed in a Phase I trial involving children with acute lymp hoblastic leukemia (ALL) and AML. Therefore, a pediatric Phase II stud y was undertaken to determine the degree of activity of carboplatin in childhood ALL and AML. METHODS. Between October 1991 and November 199 4, the Children's Cancer Group conducted a Phase II study of carboplat in given by 5-day continuous intravenous infusion to children with acu te leukemia recurring in bone marrow. RESULTS. Minimal antileukemic ac tivity was demonstrated in patients with ALL and AML. One of 21 eligib le patients with ALL, achieved a partial response. Of 23 eligible pati ents with AML, including 1 patient with chronic myelogenous leukemia i n blast crisis, 1 had hypocellular M1 bone marrow with a platelet coun t of 15,000/mm(3), and 2 achieved partial responses. Nonhematologic to xicities, which were infrequent, included mild hepatic and renal dysfu nction. CONCLUSIONS. In this pediatric Phase II trial of carboplatin a s a treatment for acute leukemia, minimal activity was demonstrated in patients with ALL and AML recurring in bone marrow. Further evaluatio n of carboplatin as a treatment for childhood leukemia, using the dose schedule of 216 mg/m(2)/day given by 5-day continuous intravenous inf usion, does not appear warranted. (C) 1997 American Cancer Society.