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| ID | Type | Description | Link |
|---|---|---|---|
| SIOP-MMT-98 | |||
| SFOP-SIOP-MMT-98 | |||
| CCLG-SIOP-MMT-98 | |||
| EU-20126 | |||
| STS-1998 |
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| Name | Class |
|---|---|
| Children's Cancer and Leukaemia Group | OTHER |
| Societe Francaise Oncologie Pediatrique | OTHER |
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.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to risk group (standard vs high).
Standard-risk patients:
Patients with parameningeal disease undergo radiotherapy 5 days a week for about 8 weeks beginning at week 9.
Patients who remain in PR at week 17 undergo radiotherapy for about 9 weeks beginning at week 18.
High-risk patients:
Patients receive high-dose cyclophosphamide IV over 1 hour on days 1-3 of week 7. Beginning on day 8, patients receive filgrastim (G-CSF) IV or subcutaneously (SC) daily until day 13. Patients may undergo peripheral blood stem cell (PBSC) collection.
Patients receive high-dose etoposide IV over 24 hours on days 15-17. Beginning on day 22, patients receive G-CSF IV or SC daily until day 27.
Patients receive high-dose cyclophosphamide IV over 1 hour on days 29-31. Beginning on day 36, patients receive G-CSF IV or SC daily until day 42. Patients may undergo PBSC collection if not previously performed. Patients who achieve complete response (CR) are removed from study.
Patients receive high-dose carboplatin IV over 1 hour on days 44-48. Patients undergo PBSC reinfusion on day 52. Beginning on day 55, patients receive G-CSF IV or SC daily until blood counts recover.
Patients with parameningeal disease and those not achieving CR undergo radiotherapy beginning at week 17. Patients achieving CR, unless metastatic disease is resected, undergo radiotherapy beginning on week 15.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 8-30 standard-risk patients will be accrued for this study within 4 years. A total of 15-75 high-risk patients will be accrued for this study within 4-5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dactinomycin | Biological | |||
| filgrastim | Biological | |||
| carboplatin | Drug | |||
| cyclophosphamide | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| epirubicin hydrochloride | Drug | |||
| etoposide | Drug | |||
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic rhabdomyosarcoma or other malignant mesenchymal tumors
Standard risk defined as:
High risk defined as:
Diagnosed less than 8 weeks ago
Previously untreated disease except for initial surgery within the past 8 weeks
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Leon Berard | Lyon | 69373 | France | |||
| Our Lady's Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20338746 | Result | 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. |
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| ifosfamide |
| Drug |
| vincristine sulfate | Drug |
| peripheral blood stem cell transplantation | Procedure |
| radiation therapy | Radiation |
| Crumlin |
| 12 |
| Ireland |
| Birmingham Children's Hospital | Birmingham | England | B4 6NH | United Kingdom |
| Bristol Royal Hospital for Children | Bristol | England | BS2 8BJ | United Kingdom |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 2QQ | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England | L12 2AP | United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| Leeds Cancer Centre at St. James's University Hospital | London | England | W6 8RF | United Kingdom |
| Great Ormond Street Hospital for Children NHS Trust | London | England | WC1N 3JH | United Kingdom |
| Meyerstein Institute of Oncology at University College of London Hospitals | London | England | WIT 3AA | United Kingdom |
| Central Manchester and Manchester Children's University Hospitals NHS Trust | Manchester | England | M27 4HA | United Kingdom |
| Newcastle Upon Tyne Hospitals NHS Trust | Newcastle upon Tyne | England | NE7 7DN | United Kingdom |
| Queen's Medical Centre | Nottingham | England | NG7 2UH | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Children's Hospital - Sheffield | Sheffield | England | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | Scotland | G3 8SJ | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D002813 | Chondrosarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D005354 | Fibrosarcoma |
| C562740 | Hemangiopericytoma, Malignant |
| D008080 | Liposarcoma |
| D006394 | Hemangiosarcoma |
| C535700 | Malignant mesenchymal tumor |
| D058405 | Desmoplastic Small Round Cell Tumor |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009372 | Neoplasms, Connective Tissue |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D003609 | Dactinomycin |
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D015251 | Epirubicin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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