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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.

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
Drug: carboplatin
Drug: cyclophosphamide
Drug: dactinomycin
Drug: doxorubicin hydrochloride
Drug: epirubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: ifosfamide
Drug: vincristine sulfate
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Intestinal Cancer    Ovarian Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Ifosfamide    Cyclophosphamide    Carboplatin    Filgrastim    Etoposide    Vincristine sulfate    Vincristine    Etoposide phosphate    Epirubicin hydrochloride    Epirubicin    Dactinomycin   

U.S. FDA Resources

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

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

Study Start Date:   November 1998

Show detailed description  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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068961, SIOP-MMT-98, SFOP-SIOP-MMT-98, CCLG-SIOP-MMT-98, EU-20126, STS-1998
First Received:   October 11, 2001
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00025441
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:
Fibrosarcoma
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Urogenital Neoplasms
Osteogenic sarcoma
Duodenal Neoplasms
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Dactinomycin
Neoplasm Metastasis
Neuroepithelioma
Sarcoma, Alveolar Soft Part
Etoposide
Endocrine Gland Neoplasms
Rhabdomyosarcoma
Digestive System Neoplasms
Synovial sarcoma
Genital Neoplasms, Female
Vincristine
Endocrine System Diseases
Carboplatin
Hemangiopericytoma
Doxorubicin
Neuroectodermal Tumors
Liposarcoma
Sarcoma
Gastrointestinal Neoplasms
Uterine sarcoma
Leiomyosarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Ileal Diseases
Anti-Bacterial Agents
Neoplasms by Site
Jejunal Diseases
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Protein Synthesis Inhibitors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 23, 2008




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