Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia

Inclusion Criteria:

Established diagnoses of poor-risk hematologic malignancies will be considered eligible for this Phase I/II study
Pathological confirmation of the diagnosis of AML or ALL
ECOG performance status 0,1,2
Patients must be able to give informed consent
Female patients of childbearing age must have negative pregnancy test
AST and ALT =< 2.5 x normal
Alkaline phosphatase =< 2.5 x normal
Bilirubin =< 1.5 x normal
Serum creatinine =< 2.0 mg/dl
Left ventricular ejection fraction must >= 45% by MUGA or Echocardiogram

Acute Myelogenous Leukemia (AML)

AML arising from MDS
Secondary AML
Relapsed or refractory AML, including primary induction failure

Acute Lymphoblastic Leukemia (ALL)

Relapsed or refractory ALL, including primary induction failure
Patients who fail primary induction therapy or who relapse after achieving complete remission (CR) are eligible if they have undergone no more than 3 prior courses of induction/reinduction
There should be an interval of at least 4 weeks from any previous intensive chemotherapy before beginning flavopiridol, with the exceptions non-aplasia producing treatments (i.e. hydroxyurea, interferon, imatinib, 6MP, thalidomide); patients should have recovered completely from any treatment-related toxicities; patients may have received hematopoietic growth factors previously, but must be off all growth factors (including EPO, G-CSF, GM-CSF, IL-3, IL-11) for at least 4 days prior to beginning flavopiridol
Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic, are eligible provided that they are >= 4 weeks from stem cell infusion, have no active GVHD, and meet other eligibility criteria

Exclusion Criteria:

Hyperleukocytosis with >= 50,000 leukemic blasts/mm^3
Active, uncontrolled infection
Disseminated intravascular coagulation
Active CNS leukemia
Concomitant chemotherapy, radiation therapy or immunotherapy
Intrinsic impaired cardiac function (MI within the preceding 3 months or history of severe coronary artery disease, cardiomyopathy, CHF > Class II)
History of congestive heart disease, or arrhythmia without regard to time, severity or resolution
Women who are pregnant or lactating will not be eligible for this trial, as the investigational agent may be harmful to the developing fetus or nursing infant