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

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Brief Title

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

Official Title

Dose Escalation Study of Clofarabine in Combination With Cytarabine (Ara-C) and G-CSF Priming for Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients

Brief 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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose of Clofarabine

Secondary Outcome

 Hematologic and Non-hematologic Side Effect Profile

Condition

Acute Myeloid Leukemia

Intervention

clofarabine

Study Arms / Comparison Groups

 Arm I
Description:  See Detailed Description

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

December 2007

Completion Date

April 2015

Primary Completion Date

March 2010

Eligibility Criteria

        Inclusion Criteria:

          -  ECOG performance status 0-2

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment

          -  Male and female patients must be willing to use an effective contraceptive method
             during the study and for a minimum of 6 months after study treatment

          -  Serum Total or Direct bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 times ULN

          -  Diagnosis of acute myeloid leukemia by WHO criteria, either relapsed or refractory;
             acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and
             variants] would be eligible only after failure of a regimen containing arsenic
             trioxide

          -  Serum creatinine =< 1.0 mg/dL; if serum creatinine > 1.0 mg/dl, then the estimated
             glomerular filtration rate (GFR) must be >60 mL/min/1.73 m^2

          -  Alkaline phosphatase =< 2.5 times ULN

        Exclusion Criteria:

          -  Use of investigational agents within 30 days or initiation of any other anticancer
             therapy within 2 weeks before study entry with the exception of hydroxyurea, and
             intrathecal therapy for leukemic meningitis

          -  Patients with a systemic fungal, bacterial, viral, or other infection not controlled
             (defined as exhibiting ongoing signs/symptoms related to the infection and without
             improvement, despite appropriate antibiotics or other treatment)

          -  Pregnant or lactating patients

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results

          -  Have any other severe concurrent disease, history of serious organ dysfunction, or
             disease involving the heart, kidney, liver (including symptomatic hepatitis,
             veno-occlusive disease, or hepatic graft-versus-host disease [for acute >= grade 2]),
             or other organ system dysfunction

          -  No concomitant cytotoxic therapy or investigational therapy is allowed during the
             study with the exception of intrathecal therapy for leukemic meningitis; intrathecal
             therapy must not be given during or within 24 hours of any 5 day
             Clofarabine/Cytarabine treatment period

          -  To the extent possible, use of nephrotoxic (e.g., vancomycin, amphotericin B, etc) and
             hepatotoxic (e.g., voriconazole, cyclosporine, etc) agents is to be avoided during
             clofarabine; use of alternative medications (e.g., herbal or botanical for anticancer
             purposes) is not permitted during the entire study period

          -  Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol

          -  More than two failed induction attempts for initial diagnosis or current relapse; for
             patients enrolled under part III of the protocol, patients must be at first salvage
             after relapse less than one year from complete remission, or salvage after initial
             induction chemotherapy

          -  Allogeneic transplant recipients on immunosuppression or on treatment for GVHD
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Pamela Becker, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00602225

Organization ID

6562

Secondary IDs

NCI-2009-01464

Responsible Party

Principal Investigator

Study Sponsor

University of Washington

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Pamela Becker, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Verification Date

February 2018