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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.
 
ClinicalTrials.gov Identifier: NCT00276692
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : June 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date June 26, 2013
Study Start Date  ICMJE August 2003
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Response as measured by MRI following course 2
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00276692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
Official Title  ICMJE Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma
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.

Detailed Description

OBJECTIVES:

Primary

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: irinotecan hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
35
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No more than 45 days since prior definitive biopsy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276692
Other Study ID Numbers  ICMJE CCLG-ET-2003-04
CDR0000454550 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20582
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Children's Cancer and Leukaemia Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bruce Morland, MD Birmingham Children’s Hospital
PRS Account National Cancer Institute (NCI)
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP