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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cytarabine
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • Children's Hospital Central California
  • Children's Hospital of Orange County
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Lee Cancer Care of Lee Memorial Health System
  • All Children's Hospital
  • St. Joseph's Cancer Institute at St. Joseph's Hospital
  • Kaplan Cancer Center at St. Mary's Medical Center
  • Cancer Research Center of Hawaii
  • Children's Memorial Hospital - Chicago
  • Simmons Cooper Cancer Institute
  • Indiana University Melvin and Bren Simon Cancer Center
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Tulane Cancer Center Office of Clinical Research
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  • Massachusetts General Hospital
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • C.S. Mott Children's Hospital at University of Michigan Medical Center
  • Hurley Medical Center
  • Butterworth Hospital at Spectrum Health
  • University of Mississippi Cancer Clinic
  • Children's Mercy Hospital
  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
  • Sunrise Hospital and Medical Center
  • Hackensack University Medical Center Cancer Center
  • Overlook Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • University of New Mexico Cancer Center
  • NYU Cancer Institute at New York University Medical Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
  • Stony Brook University Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Akron Children's Hospital
  • Rainbow Babies and Children's Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Columbus Children's Hospital
  • Children's Medical Center - Dayton
  • Oklahoma University Cancer Institute
  • Legacy Emanuel Hospital and Health Center and Children's Hospital
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Rhode Island Hospital Comprehensive Cancer Center
  • Hollings Cancer Center at Medical University of South Carolina
  • Palmetto Health South Carolina Cancer Center
  • Greenville Hospital Cancer Center
  • East Tennessee Children's Hospital
  • Texas Tech University Health Sciences Center School of Medicine - Amarillo
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Cook Children's Medical Center - Fort Worth
  • Baylor University Medical Center - Houston
  • M. D. Anderson Cancer Center at University of Texas
  • Methodist Children's Hospital of South Texas
  • Primary Children's Medical Center
  • Children's Hospital of The King's Daughters
  • Children's Hospital and Regional Medical Center - Seattle
  • West Virginia University Health Sciences Center - Charleston
  • Marshfield Clinic - Marshfield Center
  • Midwest Children's Cancer Center
  • Princess Margaret Hospital for Children
  • University of Alberta Hospital
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Children's Hospital of Eastern Ontario
  • Hospital for Sick Children
  • Montreal Children's Hospital at McGill University Health Center
  • Hopital Sainte Justine
  • Centre Hospitalier Universitaire de Quebec
  • San Jorge Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytarbine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2007
Last Updated
October 9, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00470275
Brief Title
Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
Official Title
Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cytarbine
Arm Type
Experimental
Arm Description
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
Intervention Type
Drug
Intervention Name(s)
cytarabine
Other Intervention Name(s)
cytosine arabinoside, Ara-C, Cytosar, NSC #063878
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response
Description
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)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Stegmaier, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Holcombe E. Grier, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242-2814
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Simmons Cooper Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9677
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Tulane Cancer Center Office of Clinical Research
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71315-3198
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
C.S. Mott Children's Hospital at University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0286
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Stony Brook University Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9446
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Hospital and Health Center and Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Greenville Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor University Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1971
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
West Virginia University Health Sciences Center - Charleston
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18989890
Citation
DuBois SG, Krailo MD, Lessnick SL, Smith R, Chen Z, Marina N, Grier HE, Stegmaier K; Children's Oncology Group. Phase II study of intermediate-dose cytarabine in patients with relapsed or refractory Ewing sarcoma: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2009 Mar;52(3):324-7. doi: 10.1002/pbc.21822.
Results Reference
result

Learn more about this trial

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

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