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Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276692
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as irinotecan, 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 irinotecan works in treating patients with newly diagnosed Ewing's sarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: irinotecan hydrochloride Phase 2

Detailed Description:



  • Assess the responsiveness of single-agent irinotecan hydrochloride in a patient population with newly diagnosed high-risk Ewing's sarcoma.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan hydrochloride IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses. After completion of 2 courses of therapy, patients may receive additional treatment at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma
Study Start Date : August 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : July 2009

Primary Outcome Measures :
  1. Response as measured by MRI following course 2

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed Ewing's tumor

    • Ewing's sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue
    • High-risk disease (R3), defined as metastases at extrapulmonary/pleural sites
  • Newly diagnosed disease
  • Measurable primary and/or metastatic disease

    • At least one bidimensionally measurable lesion
  • Concurrent enrollment on EURO-Ewing99 clinical trial required


  • No abnormal cardiac function, including any of the following:

    • Fractional shortening < 29%
    • Ejection fraction < 40%
  • Glomerular filtration rate ≥ 60mL/min
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No prior or current history of chronic diarrhea, bowel obstruction, sub obstruction, Crohn's disease, or ulcerative colitis
  • No other medical, psychiatric, or social condition incompatible with the study treatment


  • No prior chemotherapy
  • No more than 45 days since prior definitive biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276692

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Sponsors and Collaborators
Children's Cancer and Leukaemia Group
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Study Chair: Bruce Morland, MD Birmingham Children's Hospital
Layout table for additonal information Identifier: NCT00276692    
Other Study ID Numbers: CCLG-ET-2003-04
CDR0000454550 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
Additional relevant MeSH terms:
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Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents