CClinicalTrials.gg
CompletedNCT00276692Updated Jun 26, 2013

Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

A Phase 2 interventional study of irinotecan hydrochloride in Sarcoma, sponsored by Children's Cancer and Leukaemia Group. Completed at 21 sites in 2 countries. Open to participants aged Up to 19 Years. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by Children's Cancer and Leukaemia Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Ages
Up to 19 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcoma

Keywords

  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 35 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Children's Cancer and Leukaemia Group is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
35 participants (estimated)

Interventions

  • Drugirinotecan hydrochloride
06

What researchers measure

Primary outcomes

  1. Response as measured by MRI following course 2

07

Study locations

21 sites
  • Our Lady's Hospital for Sick Children Crumlin
    Dublin, 12, Ireland
  • Birmingham Children's Hospital
    Birmingham, England B4 6NH, United Kingdom
  • Institute of Child Health at University of Bristol
    Bristol, England BS2 8AE, United Kingdom
  • Addenbrooke's Hospital
    Cambridge, England CB2 2QQ, United Kingdom
  • Leeds Cancer Centre at St. James's University Hospital
    Leeds, England LS9 7TF, United Kingdom
  • Leicester Royal Infirmary
    Leicester, England LE1 5WW, United Kingdom
  • Royal Liverpool Children's Hospital, Alder Hey
    Liverpool, England L12 2AP, United Kingdom
  • Royal London Hospital
    London, England E1 1BB, United Kingdom
  • Great Ormond Street Hospital for Children
    London, England WC1N 3JH, United Kingdom
  • Royal Manchester Children's Hospital
    Manchester, England M27 4HA, United Kingdom
  • Sir James Spence Institute of Child Health at Royal Victoria Infirmary
    Newcastle-Upon-Tyne, England NE1 4LP, United Kingdom
  • Queen's Medical Centre
    Nottingham, England NG7 2UH, United Kingdom
  • Oxford Radcliffe Hospital
    Oxford, England 0X3 9DU, United Kingdom
  • Children's Hospital - Sheffield
    Sheffield, England S10 2TH, United Kingdom
  • Southampton General Hospital
    Southampton, England SO16 6YD, United Kingdom
  • Royal Marsden - Surrey
    Sutton, England SM2 5PT, United Kingdom
  • Royal Belfast Hospital for Sick Children
    Belfast, Northern Ireland BT12 6BE, United Kingdom
  • Royal Aberdeen Children's Hospital
    Aberdeen, Scotland AB25 2ZG, United Kingdom
  • Royal Hospital for Sick Children
    Edinburgh, Scotland EH9 1LF, United Kingdom
  • Royal Hospital for Sick Children
    Glasgow, Scotland G3 8SJ, United Kingdom
  • Childrens Hospital for Wales
    Cardiff, Wales CF14 4XW, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00276692
Lead sponsor
Children's Cancer and Leukaemia Group
First posted
Jan 13, 2006
Start date
Aug 2003
Primary completion
Sep 2008
Completion
Jul 2009
Last update
Jun 26, 2013

Study contacts

Bruce Morland, MD
study chair · Birmingham Children's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion