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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00025441
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
Sponsor:
Collaborators:
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood
Study Start Date : November 1998
Actual Study Completion Date : March 2010






Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025441


Locations
Show Show 22 study locations
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Investigators
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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
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00025441    
Other Study ID Numbers: CDR0000068961
SIOP-MMT-98
SFOP-SIOP-MMT-98
CCLG-SIOP-MMT-98
EU-20126
STS-1998
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: November 2001
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
Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Intestinal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Myosarcoma
Neoplasms, Muscle Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Dactinomycin
Cyclophosphamide
Ifosfamide
Carboplatin
Doxorubicin
Liposomal doxorubicin
Etoposide
Vincristine
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action