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

This study has been completed.
Sponsor:
Collaborators:
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025441
First received: October 11, 2001
Last updated: December 3, 2013
Last verified: November 2001
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Sarcoma
Small Intestine Cancer
Biological: dactinomycin
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: epirubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: vincristine sulfate
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1998
Study Completion Date: March 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025441

Locations
France
Centre Leon Berard
Lyon, France, 69373
Ireland
Our Lady's Hospital for Sick Children
Crumlin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Leeds Cancer Centre at St. James's University Hospital
London, England, United Kingdom, W6 8RF
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Investigators
Study Chair: Heather P. McDowell, MD Royal Liverpool Children's Hospital, Alder Hey
Study Chair: Annabel B.M. Foot Bristol Royal Hospital for Children
Study Chair: Christophe Bergeron Centre Leon Berard
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025441     History of Changes
Other Study ID Numbers: CDR0000068961, SIOP-MMT-98, SFOP-SIOP-MMT-98, CCLG-SIOP-MMT-98, EU-20126, STS-1998
Study First Received: October 11, 2001
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood alveolar soft-part sarcoma
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 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

Additional relevant MeSH terms:
Ovarian Neoplasms
Rhabdomyosarcoma
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Sarcoma
Intestinal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Jejunal Diseases
Dactinomycin

ClinicalTrials.gov processed this record on April 17, 2014