Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Societe Internationale d'Oncologie Pediatrique
Collaborators:
Children's Cancer and Leukaemia Group
Societe Francaise Oncologie Pediatrique
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025441
First received: October 11, 2001
Last updated: April 1, 2010
Last verified: November 2001
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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 |
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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood |
Resource links provided by NLM:
Genetics Home Reference related topics:
Ewing sarcoma
Drug Information available for:
Cyclophosphamide
Dactinomycin
Vincristine sulfate
Ifosfamide
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Carboplatin
Epirubicin hydrochloride
Epirubicin
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
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 | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Leeds Cancer Centre at St. James's University Hospital | |
| London, England, United Kingdom, W6 8RF | |
| Great Ormond Street Hospital for Children NHS Trust | |
| London, England, United Kingdom, WC1N 3JH | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Meyerstein Institute of Oncology at University College of London Hospitals | |
| London, England, United Kingdom, WIT 3AA | |
| 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 | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden NHS Foundation Trust - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025441 History of Changes |
| Other 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: | April 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
childhood epithelioid sarcoma 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 malignant mesenchymoma stage IV uterine sarcoma uterine leiomyosarcoma ovarian sarcoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Rhabdomyosarcoma Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Sarcoma Intestinal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Dactinomycin |
ClinicalTrials.gov processed this record on May 23, 2013