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Status:

COMPLETED

Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

All Genders

Up to 30 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase...

Detailed Description

OBJECTIVES: * Determine the response rate in younger patients with recurrent or refractory Ewing's sarcoma treated with cytarabine. OUTLINE: This is a multicenter study. Patients receive cytarabine...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed Ewing's sarcoma or primitive neuroectodermal tumor (PNET)
  • Disease that has recurred or not responded despite prior therapy
  • Has declined enrollment on or is not eligible for clinical trial COG-AEWS0521
  • Must have at least one site of measurable disease involving lung or soft tissue as documented by CT scan and/or MRI
  • No disease limited to bone
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
  • Life expectancy ≥ 8 weeks
  • ANC ≥ 750/mm\^3
  • Platelet count ≥ 75,000/mm\^3 (50,000/mm\^3 if documented bone marrow metastatic disease) (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age and \< 2.0 mg/dL
  • ALT ≤ 2.5 times ULN
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR creatinine meeting the following criteria:
  • ≤ 0.4 mg/dL (1 month to \< 6 months of age)
  • ≤ 0.5 mg/dL (6 months to \< 1 year of age)
  • ≤ 0.6 mg/dL (1 to \< 2 years of age)
  • ≤ 0.8 mg/dL (2 to \< 6 years of age)
  • ≤ 1.0 mg/dL (6 to \< 10 years of age)
  • ≤ 1.2 mg/dL (10 to \< 13 years of age)
  • ≤ 1.4 mg/dL (≥ 13 years of age) (female)
  • ≤ 1.5 mg/dL (13 to \< 16 years of age) (male)
  • ≤ 1.7 mg/dL (≥ 16 years of age) (male)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection, including systemic fungal infections requiring ongoing antifungal therapy
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from all prior tumor-directed therapy
  • At least 7 days since prior biologic therapy or immunotherapy
  • At least 1 week since prior hematopoietic growth factors (2 weeks for pegfilgrastim)
  • At least 2 weeks since prior myelosuppressive chemotherapy
  • At least 2 weeks since prior local palliative (small-port) radiotherapy
  • At least 6 weeks since prior substantial bone marrow radiotherapy
  • At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
  • At least 6 months since prior autologous stem cell transplantation
  • No prior allogeneic stem cell transplantation
  • No prior cytarabine
  • No other concurrent investigational agents, including chemotherapy, immunotherapy, or biologic therapy
  • No other concurrent anticancer chemotherapy or immunomodulating agents
  • Concurrent corticosteroids allowed
  • No concurrent intrathecal chemotherapy
  • Concurrent radiotherapy to localized painful lesions allowed provided at least one measurable lesion is not irradiated (no irradiated lesion may be used to assess tumor response)

Exclusion

    Key Trial Info

    Start Date :

    May 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2013

    Estimated Enrollment :

    10 Patients enrolled

    Trial Details

    Trial ID

    NCT00470275

    Start Date

    May 1 2007

    End Date

    December 1 2013

    Last Update

    October 20 2014

    Active Locations (73)

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    Page 1 of 19 (73 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724-5024

    3

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    4

    Southern California Permanente Medical Group

    Downey, California, United States, 90242-2814