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Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors

Primary Purpose

Ovarian Cancer, Sarcoma, Small Intestine Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dactinomycin
filgrastim
carboplatin
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
etoposide
ifosfamide
vincristine sulfate
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Societe Internationale d'Oncologie Pediatrique
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring chondrosarcoma, small intestine leiomyosarcoma, fibrosarcomatous osteosarcoma, embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, pleomorphic childhood rhabdomyosarcoma, mixed childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, metastatic childhood soft tissue sarcoma, extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood fibrosarcoma, childhood synovial sarcoma, childhood malignant hemangiopericytoma, childhood liposarcoma, childhood alveolar soft-part sarcoma, childhood leiomyosarcoma, childhood angiosarcoma, childhood epithelioid sarcoma, childhood malignant mesenchymoma, stage IV uterine sarcoma, uterine leiomyosarcoma, ovarian sarcoma, previously untreated childhood rhabdomyosarcoma, childhood desmoplastic small round cell tumor

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic rhabdomyosarcoma or other malignant mesenchymal tumors Standard risk defined as: Less than 10 years of age No bone or bone marrow involvement High risk defined as: At least 10 years of age OR Bone or bone marrow involvement Diagnosed less than 8 weeks ago Previously untreated disease except for initial surgery within the past 8 weeks PATIENT CHARACTERISTICS: Age: 6 months to under 18 years Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics

Sites / Locations

  • Centre Leon Berard
  • Our Lady's Hospital for Sick Children
  • Birmingham Children's Hospital
  • Bristol Royal Hospital for Children
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Saint Bartholomew's Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Great Ormond Street Hospital for Children NHS Trust
  • Meyerstein Institute of Oncology at University College of London Hospitals
  • Central Manchester and Manchester Children's University Hospitals NHS Trust
  • Newcastle Upon Tyne Hospitals NHS Trust
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Royal Belfast Hospital for Sick Children
  • Aberdeen Royal Infirmary
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
December 3, 2013
Sponsor
Societe Internationale d'Oncologie Pediatrique
Collaborators
Children's Cancer and Leukaemia Group, Societe Francaise Oncologie Pediatrique
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1. Study Identification

Unique Protocol Identification Number
NCT00025441
Brief Title
Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
Official Title
MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Societe Internationale d'Oncologie Pediatrique
Collaborators
Children's Cancer and Leukaemia Group, Societe Francaise Oncologie Pediatrique

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors.
Detailed Description
OBJECTIVES: Determine the overall survival of children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors treated with one of two different chemotherapy regimens based upon risk group. Determine the role of low-intensity maintenance chemotherapy after intensive conventional chemotherapy in standard-risk children. Determine the value of a therapeutic window in high-risk children. Determine the role of sequential high-dose chemotherapy with peripheral blood stem cell transplantation in achieving complete response in high-risk children. Determine the complete response, overall survival, and event-free survival in high-risk children. OUTLINE: This is a multicenter study. Patients are stratified according to risk group (standard vs high). Standard-risk patients: Initial chemotherapy: Patients receive vincristine IV on day 1 for weeks 1-7. Patients also receive dactinomycin IV on day 1 and ifosfamide IV over 1 hour on days 1-3 of week 1. Patients then receive carboplatin IV over 1 hour and epirubicin IV over 6 hours on day 1 of week 4. Patients then receive ifosfamide IV over 1 hour and etoposide IV over 4 hours on days 1-3 of week 7. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. After the second course, patients with less than 50% partial response (PR) are removed from study. Patients with parameningeal disease undergo radiotherapy 5 days a week for about 8 weeks beginning at week 9. Maintenance chemotherapy: Patients receive cyclophosphamide IV over 1 hour, vincristine IV, and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients who remain in PR at week 17 undergo radiotherapy for about 9 weeks beginning at week 18. High-risk patients: Initial chemotherapy: Patients receive window study drug carboplatin IV over 1 hour or doxorubicin on day 1. Treatment repeats every 3 weeks for 2 courses. Patients receive high-dose cyclophosphamide IV over 1 hour on days 1-3 of week 7. Beginning on day 8, patients receive filgrastim (G-CSF) IV or subcutaneously (SC) daily until day 13. Patients may undergo peripheral blood stem cell (PBSC) collection. Patients receive high-dose etoposide IV over 24 hours on days 15-17. Beginning on day 22, patients receive G-CSF IV or SC daily until day 27. Patients receive high-dose cyclophosphamide IV over 1 hour on days 29-31. Beginning on day 36, patients receive G-CSF IV or SC daily until day 42. Patients may undergo PBSC collection if not previously performed. Patients who achieve complete response (CR) are removed from study. Patients receive high-dose carboplatin IV over 1 hour on days 44-48. Patients undergo PBSC reinfusion on day 52. Beginning on day 55, patients receive G-CSF IV or SC daily until blood counts recover. Maintenance chemotherapy: Patients receive maintenance chemotherapy comprising cyclophosphamide, vincristine, and dactinomycin in the same manner as the standard-risk patients. Patients with parameningeal disease and those not achieving CR undergo radiotherapy beginning at week 17. Patients achieving CR, unless metastatic disease is resected, undergo radiotherapy beginning on week 15. Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 8-30 standard-risk patients will be accrued for this study within 4 years. A total of 15-75 high-risk patients will be accrued for this study within 4-5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Sarcoma, Small Intestine Cancer
Keywords
chondrosarcoma, small intestine leiomyosarcoma, fibrosarcomatous osteosarcoma, embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, pleomorphic childhood rhabdomyosarcoma, mixed childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, metastatic childhood soft tissue sarcoma, extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood fibrosarcoma, childhood synovial sarcoma, childhood malignant hemangiopericytoma, childhood liposarcoma, childhood alveolar soft-part sarcoma, childhood leiomyosarcoma, childhood angiosarcoma, childhood epithelioid sarcoma, childhood malignant mesenchymoma, stage IV uterine sarcoma, uterine leiomyosarcoma, ovarian sarcoma, previously untreated childhood rhabdomyosarcoma, childhood desmoplastic small round cell tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
dactinomycin
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic rhabdomyosarcoma or other malignant mesenchymal tumors Standard risk defined as: Less than 10 years of age No bone or bone marrow involvement High risk defined as: At least 10 years of age OR Bone or bone marrow involvement Diagnosed less than 8 weeks ago Previously untreated disease except for initial surgery within the past 8 weeks PATIENT CHARACTERISTICS: Age: 6 months to under 18 years Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather P. McDowell, MD
Organizational Affiliation
Royal Liverpool Children's Hospital, Alder Hey
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Annabel B.M. Foot
Organizational Affiliation
Bristol Royal Hospital for Children
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christophe Bergeron
Organizational Affiliation
Centre Leon Berard
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Our Lady's Hospital for Sick Children
City
Crumlin
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
Bristol Royal Hospital for Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
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
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Meyerstein Institute of Oncology at University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Central Manchester and Manchester Children's University Hospitals NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Trust
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
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 NHS Foundation Trust - 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
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20338746
Citation
McDowell HP, Foot AB, Ellershaw C, Machin D, Giraud C, Bergeron C. Outcomes in paediatric metastatic rhabdomyosarcoma: results of The International Society of Paediatric Oncology (SIOP) study MMT-98. Eur J Cancer. 2010 Jun;46(9):1588-95. doi: 10.1016/j.ejca.2010.02.051. Epub 2010 Mar 24.
Results Reference
result

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Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors

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