Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib

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