Clinical trial NCT00470275 (phase 2, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: cytarabine
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        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)