Trial Search Results

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

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 II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewing's sarcoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: cytarabine

Phase:

Phase 2

Eligibility


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)

Ages Eligible for Study

N/A - 30 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Min Wang
6507364281
Not Recruiting