Nine children with acute non-
lymphocytic leukemia (
ANLL), ages 16 months to 16 years (median 7 years), and 15 children with
acute lymphocytic leukemia (ALL), ages 10 months to 18 years (median 5 years), were treated with 5-day courses of
mitoxantrone (
Novantrone; dihydroxyanthracenedione) as induction
therapy. All the children had
leukemia which was resistant to conventional
therapy and all but one patient had received
anthracycline therapy prior to the initiation of this trial. Three patients (two with
ANLL, one with ALL) received the
drug at a dose of 6 mg/m2/day i.v. for 5 days. Both patients with
ANLL achieved partial remissions (PR) (105 and 87 days duration). The child with ALL failed to respond to two courses of the
drug, and died of progressive disease 45 days after the institution of
therapy. Twenty-one patients (14 with ALL, seven with
ANLL) were treated with 8 mg/m2/day i.v.
mitoxantrone for 5 days. There were three early deaths (all ALL) which were not felt to be secondary to
drug toxicity. Four of the 18 children achieved complete remission (CR) (one
ANLL - 35 days; three ALL - 39, 31 and 13 days). One child with
ANLL achieved a PR (13 days) and one child with ALL showed improvement in his bone marrow status. Twelve children failed to respond to this
therapy. Dose-limiting toxicity was not seen among the patients who received 6 mg/m2/day for 5 days. There were five patients who had
mucositis and one patient who had
nausea and
vomiting among those patients who received 8 mg/m2/day for 5 days.(ABSTRACT TRUNCATED AT 250 WORDS)