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

Children's Oncology Group

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Treatments

Drug: cytarabine

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00470275

CDR0000542650 (Other Identifier)

AEWS0621

COG-AEWS0621 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

10 patients

Sex

All

Ages

Under 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)