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Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025441
  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 II

Study Type: Interventional
Study Design: 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
  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, England
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Leeds Cancer Centre at St. James's University Hospital
London, England, United Kingdom, W6 8RF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
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
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
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:
No publications provided

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: February 6, 2009
ClinicalTrials.gov Identifier: NCT00025441     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Anti-Infective Agents
Fibrosarcoma
Neuroectodermal Tumors, Primitive
Urogenital Neoplasms
Ileal Diseases
Duodenal Neoplasms
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Dactinomycin
Neoplasm Metastasis
Ovarian Cancer
Neuroepithelioma
Osteogenic Sarcoma
Sarcoma, Alveolar Soft Part
Etoposide
Endocrine Gland Neoplasms
Rhabdomyosarcoma
Digestive System Neoplasms
Genital Neoplasms, Female
Vincristine
Endocrine System Diseases
Carboplatin
Hemangiopericytoma
Ewing's Sarcoma
Doxorubicin
Neuroectodermal Tumors
Liposarcoma
Malignant Mesenchymal Tumor
Uterine Sarcoma
Sarcoma

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urogenital Neoplasms
Ileal Diseases
Duodenal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Dactinomycin
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Myosarcoma
Genital Neoplasms, Female
Endocrine System Diseases
Vincristine
Carboplatin
Doxorubicin
Neoplasms
Sarcoma
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Neoplasms, Muscle Tissue
Immunologic Factors
Gastrointestinal Diseases
Gonadal Disorders
Antineoplastic Agents
Ovarian Diseases

ClinicalTrials.gov processed this record on September 02, 2009