arsenic trioxide in treating patients with relapsed or refractory acute lymphoblastic leukemia

Conditions: Leukemia

Summary: 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.

Eligibility criteria:
disease characteristics: * morphologically proven acute lymphoblastic leukemia (all) * subtypes l1, l2, or l3 * bone marrow morphology with greater than 25% lymphoblasts * all morphology and cytochemistry with myeloid markers eligible * refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation * any number of prior relapses allowed * no relapse following allogeneic transplantation * prior cns leukemia allowed if treated and currently disease-free patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 6 months hematopoietic: * not specified hepatic: * bilirubin no greater than 2.0 mg/dl * sgot/sgpt no greater than 2 times upper limit of normal (uln) * alkaline phosphatase no greater than 2 times uln renal: * creatinine no greater than 2 mg/dl other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no significant active infection * no other medical conditions that would likely decrease life expectancy * no other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * see disease characteristics endocrine therapy: * at least 2 weeks since prior systemic corticosteroids radiotherapy: * not specified surgery: * not specified other: * no concurrent antibiotics for active or resolving infection

Keywords: recurrent adult acute lymphoblastic leukemia l1 adult acute lymphoblastic leukemia l2 adult acute lymphoblastic leukemia l3 adult acute lymphoblastic leukemia