Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Promyelocytic Leukemia (M3); Recurrent Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different
      ways to stop the growth of cancer cells, either by killing the cells or stopping them from
      dividing. Colony stimulating factors, such as G-CSF, may increase the number of immune cells
      found in bone marrow or peripheral blood and may help the immune system recover from the side
      effects of chemotherapy.

      PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine to see
      how well it works when given together with cytarabine and G-CSF in treating patients with
      relapsed or refractory acute myeloid leukemia
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose of clofarabine, and the dose-limiting toxicities
      of the combination of clofarabine and cytarabine with G-CSF priming, in the treatment of
      patients with relapsed or refractory AML.

      SECONDARY OBJECTIVES:

      I. To determine the hematological and non-hematological side effect profile of the
      combination of clofarabine, cytarabine, and G-CSF.

      II. To determine the efficacy of clofarabine in combination with cytarabine and G-CSF priming
      in the treatment of patients with relapsed or refractory AML.

      III. To determine the disease-free and overall survival after therapy with clofarabine,
      cytarabine, and G-CSF for relapsed or refractory AML.

      OUTLINE: This is a dose escalation study of clofarabine.

      PART I:

      INDUCTION THERAPY: Patients receive clofarabine IV over 1 hour and cytarabine IV over 2 hours
      on days 1-5, and filgrastim (G-CSF) subcutaneously once daily beginning 24 hours prior to
      chemotherapy and continuing until blood count recover. Patients with residual leukemia (>= 5%
      blasts by morphology) at day 14 and if blast remain > 5% by day 21 receive a second course of
      induction therapy.

      CONSOLIDATION THERAPY: Patients receive clofarabine, cytarabine, and G-CSF as in induction
      therapy. Patients may receive a second course of consolidation therapy depending on response
      and whether additional therapy (e.g., stem cell transplant or donor lymphocyte infusion) is
      planned.

      PARTS II and III:

      Patients receive induction therapy and consolidation therapy as in part 1.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then annually for 3 years.
    

Intervention name(s): clofarabine; cytarabine; filgrastim
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Given IV; Given IV; Given subcutaneously
Other intervention name(s): CAFdA; Clofarex; Clolar; ARA-C; arabinofuranosylcytosine; arabinosylcytosine; Cytosar-U; cytosine arabinoside; G-CSF; Neupogen
Intervention MeSH terms: Cytarabine; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment