RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.
OBJECTIVES: * Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide. * Determine the toxic effects of induction arsenic trioxide in this patient population. OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week). Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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