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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00470275




Registration number
NCT00470275
Ethics application status
Date submitted
3/05/2007
Date registered
7/05/2007
Date last updated
20/10/2014

Titles & IDs
Public title
Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
Scientific title
Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma
Secondary ID [1] 0 0
CDR0000542650
Secondary ID [2] 0 0
AEWS0621
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cytarabine

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


Treatment: Drugs: cytarabine
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response
Timepoint [1] 0 0
the first six cycles of study chemotherapy (126 days)

Eligibility
Key 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)
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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Florida
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United States of America
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Hawaii
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United States of America
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Mississippi
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United States of America
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Washington
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [36] 0 0
Alberta
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Canada
State/province [37] 0 0
Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Puerto Rico
State/province [40] 0 0
Santurce

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kimberly Stegmaier, MD
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal DuBois SG, Krailo MD, Lessnick SL, Smith R, Chen Z... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00470275