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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470275 |
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 |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Disease that has recurred or not responded despite prior therapy
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR creatinine meeting the following criteria:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer chemotherapy or immunomodulating agents
Study Chair: | Kimberly Stegmaier, MD | Dana-Farber Cancer Institute |
Investigator: | Holcombe E. Grier, MD | Dana-Farber Cancer Institute |
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 |
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
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 |
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 |