Flavopiridol in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia

Inclusion Criteria:

• Histologically confirmed diagnosis of one of the following:

  • Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:

    • Refractory to initial treatment (stratum 1)
    • Recurrent disease after prior high-dose chemotherapy with or without stem cell support (stratum 1)
    • High-risk refractory disease defined as failed ≥ 2 regimens for remission induction (i.e., twice induction failure) (stratum 2)
    • High-risk relaspsed disease defined as disease in second or greater bone marrow relapse (stratum 2)

  • Chronic myelogenous leukemia in blast crisis (stratum 1)

    • Myeloid or lymphoid blast crisis that did not respond to or progressed after prior high-dose imatinib mesylate (600-800 mg/day for ≥ 2 weeks)
• No acute promyelocytic leukemia

• Ineligible for or unwilling to undergo potentially curative allogeneic or autologous stem cell transplantation

  • Patients with relapsed AML that is refractory to re-induction therapy comprising an active, intensive salvage regimen are eligible
• CNS involvement allowed provided there are no residual leukemic cells in the cerebrospinal fluid after intrathecal chemotherapy or radiotherapy
• Performance status - ECOG ≥ 2 for patients > 10 years of age
• Performance status - Lansky 50-100% for patients ≤ 10 years of age
• At least 8 weeks
• Bilirubin ≤ 2 times upper limit of normal (ULN)* (unless due to Gilbert's syndrome)
• ALT and AST ≤ 5 times ULN*
• Creatinine ≤ 2.0 mg/dL* (stratum 1)
• Creatinine > 1.3 times ULN (stratum 2)
• LVEF ≥ 40% by echocardiogram or MUGA (stratum 1)
• Shortening fraction ≥ 28% by echocardiogram (stratum 2)
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No history of allergy to study drug
• No active infection requiring IV antibiotics
• No serious medical or psychiatric illness that would preclude giving informed consent or limit survival
• No other uncontrolled illness
• See Disease Characteristics
• Recovered from all prior immunotherapy treatment-related toxicity (stratum 2)
• More than 8 weeks since prior biological agents (e.g., monoclonal antibodies) (stratum 2)
• See Disease Characteristics
• Recovered from all prior chemotherapy treatment-related toxicity (stratum 2)
• More than 24 hours since prior hydroxyurea (for patients who do not have highly proliferative disease)*
• More than 2 weeks since other prior chemotherapy (6 weeks for nitrosourea or mitomycin)
• No other concurrent chemotherapy
• Prior hydrea and/or steroids allowed (stratum 2)
• No concurrent hormones, except steroids for adrenal failure or infusional toxicity (i.e., cytokine release syndrome) or hormones for non-disease-related conditions (e.g., insulin for diabetes)
• See Disease Characteristics
• Recovered from all prior radiotherapy treatment-related toxicity (stratum 2)
• More than 2 weeks since prior radiotherapy
• No concurrent palliative radiotherapy
• Post stem cell transplant allowed provided completion ≥ 4 months prior to study entry and no evidence of active acute or chronic graft vs host disease (stratum 2)
• No other concurrent investigational agents

• No concurrent chronic systemic anticoagulant therapy for a medical condition (e.g., deep vein thrombosis or atrial fibrillation)

  • Concurrent heparin allowed to maintain central line patency (i.e., catheter flush)
• No other concurrent anticancer therapy