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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine

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)