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Status:

COMPLETED

Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Leukemia

Eligibility:

All Genders

1-30 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, work in different way...

Detailed Description

OBJECTIVES: Primary * Determine a safe, tolerable, and biologically active dose of lestaurtinib in combination with chemotherapy comprising cytarabine and idarubicin in younger patients with relapse...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of acute myeloid leukemia (AML) according to FAB classification
  • At least 5% blasts in the bone marrow, with or without extramedullary disease
  • In first relapse after induction therapy OR refractory to induction therapy with ≤ 1 attempt at remission induction
  • Patients who are in a first relapse \> 1 year from their initial diagnosis of AML are excluded from the dose-finding phase of the study, but are eligible for the efficacy phase
  • First relapse after hematopoietic stem cell transplantation (HSCT) allowed provided patient has no evidence of active graft-versus-host disease (GVHD) and is at least 4 months posttransplantation
  • Positive for a FLT3 activating mutation (internal tandem duplication or kinase domain point mutation) using standard polymerase chain reaction-based procedures at any time in the course of illness
  • Treatment-related AML allowed
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status (PS) 50-100% (\> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age and gender as follows:
  • Creatinine no greater than 0.4 mg/dL (1 month to \< 6 months of age)
  • Creatinine no greater than 0.5 mg/dL (6 months to \< 1 year of age)
  • Creatinine no greater than 0.6 mg/dL (1 year to \< 2 years of age)
  • Creatinine no greater than 0.8 mg/dL (2 years to \< 6 years of age)
  • Creatinine no greater than 1 mg/dL (6 years to \< 10 years of age)
  • Creatinine no greater than 1.2 mg/dL (10 years to \< 13 years of age)
  • Creatinine no greater than 1.4 mg/dL (females) or 1.5 mg/dL (males) (13 years to \< 16 years of age)
  • Creatinine no greater than 1.4 mg/dL (females) or 1.7 mg/dL (males) (16 years of age and over)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT \< 5 times ULN (unless it is related to leukemic involvement)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
  • PRIOR CONCURRENT THERAPY:
  • Recovered from all prior therapy
  • No prior cumulative anthracycline doses exceeding 450 mg/m\^2 daunorubicin equivalents
  • Patients who relapse after receiving treatment on protocol COG-AAML03P1 or COG-AAML0531 (300 mg/m\^2 of daunorubicin hydrochloride and 48 mg/m\^2 of mitoxantrone hydrochloride) allowed provided they have not received any additional anthracyclines
  • At least 14 days since prior cytotoxic therapy
  • Hydroxyurea allowed to decrease the WBC prior to starting protocol treatment
  • No concurrent hydroxyurea
  • At least 7 days since prior biologic agents
  • At least 14 days since prior monoclonal antibody therapy
  • Radiotherapy to chloromas allowed
  • Irradiated lesion may not be used to assess tumor response
  • No other concurrent chemotherapy, investigational therapy, immunomodulating agents, or steroids
  • Steroids used as an antiemetic allowed
  • Prophylactic intrathecal cytarabine allowed
  • No concurrent CYP3A4,5 inhibitors, including any of the following:
  • Azole antifungals (e.g., fluconazole or voriconazole)
  • Cyclosporine
  • Erythromycin
  • Clarithromycin
  • Troleandomycin
  • HIV protease inhibitors
  • Nefazodone
  • No concurrent CYP3A4,5 inducers, including any of the following:
  • Carbamazepine
  • Dexamethasone
  • Rifampin
  • Phenobarbital
  • Phenytoin
  • Hypericum perforatum (St. John's wort)

Exclusion

    Key Trial Info

    Start Date :

    June 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2010

    Estimated Enrollment :

    14 Patients enrolled

    Trial Details

    Trial ID

    NCT00469859

    Start Date

    June 1 2007

    End Date

    March 1 2010

    Last Update

    March 15 2017

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Children's Hospital of Orange County

    Orange, California, United States, 92868

    3

    Children's National Medical Center

    Washington D.C., District of Columbia, United States, 20010-2970

    4

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322