Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
OBJECTIVES: * Determine whether amifostine provides systemic protection against the nonhematologic side effects of idarubicin (IDR) during induction therapy of acute myeloid leukemia (AML), allowing the dose of idarubicin to be escalated. * Determine the maximum tolerated dose of idarubicin when amifostine is used as a chemotherapy protectant. * Determine the incidence and severity of dose limiting hypotension in patients receiving amifostine and the ability to offset this side effect with vasoconstrictive agents. * Determine whether any additional side effects of amifostine are dose limiting in patients with AML treated with IDR and cytarabine (ARA-C). * Monitor the frequency of alopecia, mucositis, diarrhea, and septicemia involving enteric pathogens in these patients. * Determine the requirement for intravenous hyperalimentation in patients receiving amifostine, IDR, and ARA-C. OUTLINE: This is a dose escalation study of idarubicin (IDR). Patients receive amifostine IV over 15 minutes, followed 15-30 minutes later by chemotherapy. Idarubicin IV is administered over 15 minutes on days 1-3. Cytarabine is administered by continuous infusion on days 1-7. Patients may receive 1 additional course of treatment, if necessary. Cohorts of 3-6 patients each are treated at each dose level of idarubicin. Dose escalation is discontinued when 2 or more patients experience dose limiting toxicity. Patients are followed at 3 months. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
