dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. purpose: this phase i trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.

objectives: primary * determine the long-term safety and tolerability of dasatinib in patients with philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resistant or intolerant to imatinib mesylate. secondary * describe any hematologic or cytogenetic response in patients treated with this drug. * determine the duration of hematologic and cytogenetic response in patients using this drug during trial ucla-0303035. * determine the progression-free survival and overall survival of patients treated with this drug. outline: this is an open-label, roll-over study of protocol ucla-0303035. patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically for 5 years. projected accrual: a total of 54 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of one of the following hematologic malignancies: * chronic phase chronic myelogenous leukemia (cml) * in complete hematologic response after treatment on protocol ucla-0303035, as indicated by the following criteria: * wbc ≤ upper limit of normal (uln) * platelet count \< 450,000/mm\^3 * no blasts or promyelocytes in peripheral blood * less than 5% myelocytes plus metamyelocytes in peripheral blood * peripheral blood basophils ≤ uln * no extramedullary involvement (including no hepatomegaly or splenomegaly) * response lasting ≥ 4 weeks after first documentation * accelerated or blastic phase cml or acute lymphoblastic leukemia * in major hematologic response\* after treatment on protocol ucla-0303035, defined as 1 of the following: * in complete hematologic response\*, as indicated by the following criteria: * wbc ≤ uln * absolute neutrophil count ≥ 1,000/mm\^3 * platelet count ≥ 100,000/mm\^3 * no blasts or promyelocytes in peripheral blood * bone marrow blasts ≤ 5% * less than 5% myelocytes plus metamyelocytes in peripheral blood * peripheral blood basophils ≤ uln * no extramedullary involvement (including no hepatomegaly or splenomegaly) * no evidence of leukemia, as indicated by the following criteria: * wbc ≤ uln * no blasts or promyelocytes in the peripheral blood * bone marrow blasts ≤ 5% * less than 5% myelocytes plus metamyelocytes in peripheral blood * peripheral blood basophils ≤ uln * no extramedullary involvement (including no hepatomegaly or splenomegaly) * absolute neutrophil count ≥ 500/mm\^3 and \< 1,000/mm\^3 and platelet count ≥ 20,000/mm\^3 and \< 100,000/mm\^3 * in minor hematologic response\* after treatment on protocol ucla-0303035, as indicated by the following criteria: * less than 15% in bone marrow and \< 15% in peripheral blood * less than 30% blasts plus promyelocytes in bone marrow and \< 30% blasts plus promyelocytes in peripheral blood * less than 20% basophils in peripheral blood * no extramedullary disease other than spleen and liver note: \*response confirmed after ≥ 4 weeks allowed provided there is no concurrent anagrelide or hydroxyurea during this time * philadelphia chromosome-positive (ph+) disease * resistant or intolerant to prior imatinib mesylate * received and benefitted from ≥ 3 months of prior therapy with dasatinib on protocol ucla-0303035 patient characteristics: * ecog performance status 0-2 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 12 weeks after completion of study treatment * no serious uncontrolled medical disorder * no active infection that would preclude study participation * no uncontrolled angina within the past 3 months * no diagnosed or suspected congenital long qt syndrome * no history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes) * qtc ≤ 450 msec on electrocardiogram * no uncontrolled hypertension * no dementia or altered mental status the would prohibit the understanding or rendering of informed consent * no history of the following significant bleeding disorders unrelated to cml: * diagnosed congenital bleeding disorders (e.g., von willebrand's disease) * diagnosed acquired bleeding disorder in the past year (e.g., acquired antifactor viii antibodies) * not involuntarily incarcerated for either psychiatric or physical (e.g., infectious disease) illness * no patients who are imprisoned * no clinical adverse event, laboratory abnormality, or intercurrent illness that may preclude study treatment, in the opinion of the investigator * bilirubin \< 1.5 mg/dl * alt and ast \< 2 times upper limit of normal (uln) * creatinine \< 1.5 times uln prior concurrent therapy: * see disease characteristics * no concurrent use of the following drugs that may confer risk of torsades de pointes: * quinidine * procainamide * disopyramide * amiodarone * sotalol * ibutilide * dofetilide * erythromycin * clarithromycin * chlorpromazine * haloperidol * mesoridazine * thioridazine * pimozide * cisapride * bepridil * droperidol * methadone * arsenic * chloroquine * domperidone * halofantrine * levomethadyl * pentamidine * sparfloxacin * lidoflazine * no other concurrent treatment for cml except for hydroxyurea for a 2-week duration * no concurrent medications that inhibit platelet function (e.g., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, or any nonsteroidal anti-inflammatory drug)\* except for hydroxyurea or anagrelide * no concurrent anticoagulants (e.g., warfarin or heparin/low molecular weight heparin \[e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin\]) except as prophylaxis for catheter thrombosis and/or heparin flushes for iv lines\* note: \*allowed if received previously on ucla-0303035

Keywords: accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia chronic myelogenous leukemia, bcr-abl1 positive