Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

07:59 EDT 1st July 2015 | BioPortfolio

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 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.

Description

OBJECTIVES:

Primary

- 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).

Secondary

- 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.

Study Design

Primary Purpose: Treatment

Conditions

Leukemia

Intervention

filgrastim, clofarabine, cytarabine

Location

Fred Hutchinson Cancer Research Center
Seattle
Washington
United States
98109-1024

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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Low efficacy and high mortality associated with clofarabine treatment of relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes.

Clofarabine, a second-generation nucleoside analog, has clinical activity in relapsed or refractory acute myelogenous leukemia (AML) and higher-risk myelodysplastic syndromes (MDS). However, there are...

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Medical and Biotech [MESH] Definitions

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

Congener of CYTARABINE that is metabolized to cytarabine and thereby maintains a more constant antineoplastic action.

A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.

A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) producing leukemia of the reticulum-cell type with massive infiltration of liver, spleen, and bone marrow. It infects DBA/2 and Swiss mice.

A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) arising during the propagation of S37 mouse sarcoma, and causing lymphoid leukemia in mice. It also infects rats and newborn hamsters. It is apparently transmitted to embryos in utero and to newborns through mother's milk.

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