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)
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 IV over 2 hours twice daily on days 1-5. Treatment repeats every
21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Comments
There are no comments for this clinical trial.
Add a new comment