NCT00276692

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2009

Enrollment Period

5.1 years

First QC Date

January 12, 2006

Last Update Submit

June 25, 2013

Conditions

Sarcoma

Keywords

metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (1)

  • Response as measured by MRI following course 2

Interventions

irinotecan hydrochlorideDRUG

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

SarcomaNeuroectodermal Tumors, Primitive, Peripheral

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Bruce Morland, MD

    Birmingham Children's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

August 1, 2003

Primary Completion

September 1, 2008

Study Completion

July 1, 2009

Last Updated

June 26, 2013

Record last verified: 2009-06

Locations

IE(1)GB(20)