Finding studies
Finding studies
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Lead
Daiichi Sankyo
OBJECTIVES: I. Determine the maximum tolerated dose of DX-8951f in patients with advanced myelodysplastic syndromes, refractory acute myeloid or lymphocytic leukemia, refractory or transformed chronic lymphocytic leukemia, or chronic myelogenous leukemia in blastic phase. II. Evaluate the quantitative and qualitative toxic effects of this regimen and determine the duration and reversibility of these effects in these patients. III. Make a preliminary determination of the antileukemic activity of this regimen in these patients. IV. Evaluate the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DX-8951f until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: Approximately 20-25 evaluable patients will be accrued for this study.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted