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

Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00470275
Enrollment
10
Registered
2007-05-07
Start date
2007-05-31
Completion date
2013-12-31
Last updated
2014-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Brief 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.

Detailed 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.

Interventions

DRUGcytarabine

Given IV

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Responsethe first six cycles of study chemotherapy (126 days)Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.

Countries

Australia, Canada, Puerto Rico, United States

Participant flow

Participants by arm

ArmCount
Cytarbine
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath1
Overall StudyLack of Efficacy7
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicCytarbine
Age, Categorical
<=18 years
4 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
8 Participants
Region of Enrollment
Canada
2 participants
Region of Enrollment
United States
8 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
10 / 10
serious
Total, serious adverse events
2 / 10

Outcome results

Primary

Response

Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.

Time frame: the first six cycles of study chemotherapy (126 days)

ArmMeasureGroupValue (NUMBER)
CytarabineResponseNon Responder10 participants
CytarabineResponseResponder0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026