Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
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
Secondary
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.
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:
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:
No evidence of leukemia, as indicated by the following criteria:
In minor hematologic response* after treatment on protocol UCLA-0303035, as indicated by the following criteria:
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:
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:
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