Finding studies
Finding studies
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Lead
Paolo Caimi, MD
With
PRIMARY OBJECTIVES: I. To determine the safety and maximum tolerated dose of the combination of tretinoin with lithium carbonate in subjects with non promyelocytic acute myeloid leukemia. SECONDARY OBJECTIVES: I. To describe the dose limiting toxicities associated with the combination of lithium (lithium carbonate) and tretinoin. II. To determine the ability of lithium to inhibit glycogen synthase kinase-3 (GSK3) activity in circulating acute myeloid leukemia (AML) cells and to enhance the retinoic acid receptor expression. III. To determine the ability of lithium and tretinoin to induce differentiation and/or growth inhibition of AML cells. IV. To determine the response rate of acute myeloid treatment to treatment with the combination of Tretinoin and Lithium. OUTLINE: This is a dose-escalation study of tretinoin. Patients receive tretinoin orally (PO) every 12 hours on days 1-7 and 15-21 and lithium carbonate PO three times daily (TID) on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
