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Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Eligibility Criteria

undefined - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady's Hospital for Sick Children Crumlin
  • Birmingham Children's Hospital
  • Institute of Child Health at University of Bristol
  • Addenbrooke's Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Royal London Hospital
  • Great Ormond Street Hospital for Children
  • Royal Manchester Children's Hospital
  • Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden - Surrey
  • Royal Belfast Hospital for Sick Children
  • Royal Aberdeen Children's Hospital
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children
  • Childrens Hospital for Wales

Outcomes

Primary Outcome Measures

Response as measured by MRI following course 2

Secondary Outcome Measures

Full Information

First Posted
January 12, 2006
Last Updated
June 25, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00276692
Brief Title
Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma
Official Title
Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Response as measured by MRI following course 2

10. Eligibility

Sex
All
Maximum Age & Unit of Time
19 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Morland, MD
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

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Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma

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