Whitehead VM et al. - In a trial to assess the use of indicine-N-oxide in children with solid tumors and leukemia, it was shown that hepatotoxicity limits the use of indicine-N-oxide in children with leukemia. Antineoplastic activity was limited to a transient reduction in the numbers of circulating leukemic cells Methods
A phase I trial of indicine-N-oxide was carried out in 12 children with solid tumors and in 16 with leukemia
Doses of 5, 6, and 7.5 g/m2 were given parenterally as a 15-min infusion every 3 weeks
Results
The maximum tolerated dose in pts with solid tumors was 7.5 g/m2 and the dose-limiting toxicity was myelosuppression
In leukemia, the maximum tolerated dose was 6.0 g/m2 and hepatotoxicity was dose-limiting
Half of the children with leukemia showed elevations in transaminase levels and 1 child died of massive hepatic necrosis
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