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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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.
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
West Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
Nova Scotia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00470275
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

Summary results
Other publications