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

NCT00025441 | Completed Phase 2

• 6 other identifiers: CDR0000068961SIOP-MMT-98SFOP-SIOP-MMT-98CCLG-SIOP-MMT-98EU-20126STS-1998
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 22

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.

Conditions

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

Interventions

dactinomycin BIOLOGICAL

filgrastim BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

vincristine sulfate DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Societe Internationale d'Oncologie Pediatrique: lead
• Children's Cancer and Leukaemia Group: collaborator
• Societe Francaise Oncologie Pediatrique: collaborator

Study Sites (22)

Centre Leon Berard

Lyon, 69373, France

Location

Our Lady's Hospital for Sick Children

Crumlin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

London, England, W6 8RF, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Meyerstein Institute of Oncology at University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20338746 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Sarcoma; Chondrosarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Fibrosarcoma; Hemangiopericytoma, Malignant; Liposarcoma; Hemangiosarcoma; Malignant mesenchymal tumor; Desmoplastic Small Round Cell Tumor

Interventions

Dactinomycin; Filgrastim; Carboplatin; Cyclophosphamide; Doxorubicin; Epirubicin; Etoposide; Ifosfamide; Vincristine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Connective Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Adipose Tissue; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 1998
• Study Completion: March 1, 2010
• Last Updated: December 4, 2013

Record last verified: 2001-11

Locations

FR (1); IE (1); GB (20)