3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
About this trial
This is an interventional treatment trial for Accelerated Phase Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of 1 of the following hematologic malignancies: Relapsed or refractory acute myeloid leukemia (AML) Relapsed or refractory acute lymphoblastic leukemia Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML Chronic myeloid leukemia in accelerated or blast phase Refractory to standard therapy or no standard therapy exists No known brain metastases Performance status - CALGB 0-2 Performance status - Karnofsky 60-100% No G6PD deficiency Bilirubin < 2.0 mg/dL (unless due to Gilbert's syndrome) AST and ALT < 2.5 times upper limit of normal (ULN) Creatinine < 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No pulmonary disease requiring oxygen Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs No neuropathy No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness No concurrent biologic agents At least 72 hours since prior hydroxyurea At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas) No other concurrent chemotherapy At least 2 weeks since prior radiotherapy No concurrent radiotherapy Recovered from all prior therapy At least 4 weeks since prior investigational agents No other concurrent investigational therapy No other concurrent anticancer therapy No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (cytarabine and triapine)
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and triapine IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.