Toxicity Study of Cytosine Arabinoside and Methotrexate in the Maintenance Therapy of Childhood Leukemia. A Southwest Oncology Group Study

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Abstract
In a toxicity study to determine the feasibility of treating patients with acute lymphocytic leukemia (ALL) using an i.v. combination of cytosine arabinoside (Ara-C) and methotrexate (MTX), the drugs were given simultaneously or sequentially every 2 wk. Patients (29) were studied, 17 treated simultaneously, 12 treated sequentially. Tolerated doses of Ara-C and MTX were 60 mg/m2 and 90 mg/m2, respectively, for the simultaneous treatment schedule and 90 mg/m2 and 150 mg/m2, respectively, for the sequential treatment schedule. The dose-limiting factor of the drug combination was gastrointestinal toxicity. Recurrent vomiting on both schedules rendered the treatment unsuitable for maintenance therapy.