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Sponsors and Collaborators: |
Societe Internationale d'Oncologie Pediatrique Children's Cancer and Leukaemia Group Societe Francaise Oncologie Pediatrique |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025441 |
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 |
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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 |
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic rhabdomyosarcoma or other malignant mesenchymal tumors
Standard risk defined as:
High risk defined as:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
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 |
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 |
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 |
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 |
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 |