Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma
This study has been completed.
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470275
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: cytarabine
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Cytarabine Cytarabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2007
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470275

  Show 73 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Kimberly Stegmaier, MD Dana-Farber Cancer Institute
Investigator: Holcombe E. Grier, MD Dana-Farber Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000542650, COG-AEWS0621
Study First Received: May 3, 2007
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00470275  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Ewing's family of tumors
Osteosarcoma
Osteogenic sarcoma
Recurrence
Soft tissue sarcomas
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Ewing's sarcoma
Peripheral neuroectodermal tumor
Sarcoma
Neuroepithelioma
Cytarabine
Neuroectodermal Tumors, Primitive, Peripheral

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms, Bone Tissue
Therapeutic Uses
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 14, 2009