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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 by 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/II 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.
- To determine the maximum tolerated dose of clofarabine, and the dose-limiting toxicities of the combination of clofarabine and cytarabine with filgrastim (G-CSF) priming, in the treatment of patients with relapsed or refractory acute myeloid leukemia (AML).
- To determine the hematological and non-hematological side effect profile of the combination of clofarabine, cytarabine, and G-CSF.
- To determine the efficacy of clofarabine in combination with cytarabine and G-CSF priming in the treatment of patients with relapsed or refractory AML.
- 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 1:
- Induction therapy: Patients receive escalating doses of 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 counts recover. Patients with residual leukemia (≥ 5% blasts by morphology) at day 14 and if blasts remain greater than 5% by day 21 receive a second course of induction therapy.
- Consolidation therapy: Patients then receive clofarabine (at a dose 5 mg/m² lower than the induction dose), 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.
- Part 2: Patients receive induction therapy as in part 1(with clofarabine at the maximum tolerated dose determined in part 1 induction therapy) and consolidation therapy as in part 1 (with clofarabine at a dose 5 mg/m² lower than the maximum tolerated dose).
After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.
Primary Purpose: Treatment
filgrastim, clofarabine, cytarabine
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:33:27-0400
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