arsenic trioxide for induction therapy of adult patients with 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 recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.

objectives: * determine the rate of clinical and hematologic response in patients with philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide. * determine the duration of hematologic response and overall survival of these patients when treated with this regimen. * determine the pattern of clinical adverse experience in these patients when treated with this regimen. * determine the pharmacokinetic profile of this regimen in these patients. outline: this is a multicenter study. patients receive arsenic trioxide iv over 2-3 hours daily for 28 days. patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course. patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter. projected accrual: a total of 24-49 patients will be accrued for this study within 2.5 years.

Eligibility criteria:
disease characteristics: * diagnosis of one of the following: * acute lymphoblastic leukemia * philadelphia chromosome (bcr-abl) positive * refractory to initial therapy or recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation * blastic phase chronic myelogenous leukemia * philadelphia chromosome (bcr-abl) positive * previously untreated or recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate * must not be eligible for bone marrow transplant patient characteristics: age: * 18 and over performance status: * eastern cooperative oncology group (ecog) 0-2 life expectancy: * at least 8 weeks hematopoietic: * not specified hepatic: * bilirubin no greater than 2.0 times upper limit of normal (uln) * ast/alt no greater than 2 times uln renal: * creatinine no greater than 2.0 times uln * creatinine clearance greater than 70 ml/min cardiovascular: * no uncontrolled angina * no new york heart association class iii or iv heart disease * no second degree heart block without pacemaker other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study * hiv negative * no uncontrolled infection or other serious concurrent illness * no peripheral neuropathy * no potassium less than 3.0 or greater than 5.5 meq/l that can not be corrected or * no magnesium less than 1.2 or greater than 2.5 meq/l that can not be corrected * electrolyte imbalances must be corrected prior to study entry prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * see disease characteristics * at least 28 days since prior chemotherapy * at least 24 hours since prior hydroxyurea * no prior arsenic trioxide * no other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for cns leukemia endocrine therapy: * not specified radiotherapy: * at least 28 days since prior radiotherapy * no concurrent radiotherapy including for palliation surgery: * not specified other: * at least 14 days since prior imatinib mesylate * no other concurrent investigational agents * no concurrent amphotericin b

Keywords: recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic myelogenous leukemia, bcr-abl1 positive lymphoid leukemia myeloid and monocytic leukemia