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Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors Clinical research trials and Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors clinical trial. Participants typically obtain the most effective healthcare available for their Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors  Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
For Condition: childhood rhabdomyosarcoma,Gastrointestinal Cancer,musculoskeletal cancer,childhood soft tissue sarcoma,Osteosarcoma,female reproductive cancer
Status: Recruiting
Sponsor(s): Societe Internationale d'Oncologie Pediatrique , United Kingdom Children's Cancer Study Group,Societe Francaise Oncologie Pediatrique
Synopsis: 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 metastaticrhabdomyosarcoma or other malignantmesenchymal tumors.
Details: OBJECTIVES: - Determine the overall survival of children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors treated with one of two different chemotherapy regimens based upon risk group. - Determine the role of low-intensity maintenance chemotherapy after intensive conventional chemotherapy in standard-risk children. - Determine the value of a therapeutic window in high-risk children. - Determine the role of sequential high-dose chemotherapy with peripheral blood stem cell transplantation in achieving complete response in high-risk children. - Determine the complete response, overall survival, and event-free survival in high-risk children. OUTLINE: This is a multicenter study. Patients are stratified according to risk group (standard vs high). Standard-risk patients: - Patients receive vincristine IV on day 1 for weeks 1-7. Patients also receive dactinomycin IV on day 1 and ifosfamide IV over 1 hour on days 1-3 of week 1. Patients then receive carboplatin IV over 1 hour and epirubicin IV over 6 hours on day 1 of week 4. Patients then receive ifosfamide IV over 1 hour and etoposide IV over 4 hours on days 1-3 of week 7. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. After the second course, patients with less than 50% partial response (PR) are removed from study. Patients with parameningeal disease undergo radiotherapy 5 days a week for about 8 weeks beginning at week 9. - Patients receive cyclophosphamide IV over 1 hour, vincristine IV, and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients who remain in PR at week 17 undergo radiotherapy for about 9 weeks beginning at week 18. High-risk patients: - Patients receive window study drug carboplatin IV over 1 hour or doxorubicin on day 1. Treatment repeats every 3 weeks for 2 courses. 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 receive maintenance chemotherapy comprising cyclophosphamide, vincristine, and dactinomycin in the same manner as the standard-risk patients. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 6 Years/17 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeatherMcDowell, Study Chair, Royal Liverpool Children's Hospital, Alder Hey
Oxford Radcliffe Hospital *Recruiting*
Oxford, England, 0X3 9DU
United Kingdom
Recruiting Kate Wheeler 44-186-522-1066
Great Ormond Street Hospital for Children NHS Trust *Recruiting*
London, England, WC1N 3JH
United Kingdom
Recruiting Penelope Brock 44-20-829-8832
Manchester Children's Hospitals (NHS Trust) *Recruiting*
Manchester, England, M27 1HA
United Kingdom
Recruiting Bernadette Brennan 44-161-727-2222
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Denise Williams 44-1223-216-878
Bristol Royal Hospital for Children *Recruiting*
Bristol, England, BS2 8BJ
United Kingdom
Recruiting Annabel Foot 44-117-921-5411
Newcastle Upon Tyne Hospitals NHS Trust *Recruiting*
Newcastle upon Tyne, England, NE7 7DN
United Kingdom
Recruiting Andrew J. Pearson 44-191-232-5131 ext. 24101
St. James's University Hospital *Recruiting*
London, England, W6 8RF
United Kingdom
Recruiting Mark Glaser 44-20-8846-1478
Our Lady's Hospital for Sick Children *Recruiting*
Crumlin, , 12
Ireland
Recruiting Fin Breatnach 353-1-409-6659
Birmingham Children's Hospital *Recruiting*
Birmingham, England, B4 6NH
United Kingdom
Recruiting Bruce Morland 44-121-333-8233
Children's Hospital - Sheffield *Recruiting*
Sheffield, England, S10 2TH
United Kingdom
Recruiting Mary Gerrard 00-44-0114-271-7229
Royal Belfast Hospital for Sick Children *Recruiting*
Belfast, Northern Ireland, BT12 6BE
United Kingdom
Recruiting Anthony Mccarthy 44-289-063-3631
Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London, England, WIT 3AA
United Kingdom
Recruiting Maria Michelagnoli 44-20-7380-9950
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting Rosemary Shannon 44-116-254-1414
Royal Hospital for Sick Children *Recruiting*
Edinburgh, Scotland,
United Kingdom
Recruiting Hamish Wallace 0131-536-0426
Royal Liverpool Children's Hospital, Alder Hey *Recruiting*
Liverpool, England, L12 2AP
United Kingdom
Recruiting Heather McDowell 44-151-228-4811
Southampton General Hospital *Recruiting*
Southampton, England, SO16 6YD
United Kingdom
Recruiting Janice Kohler 170-379-6942
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting D.J. King 44-1224-681-818
Centre Leon Berard *Recruiting*
Lyon, , 69373
France
Recruiting Christophe Bergeron 33-04-78-782642
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Judith Kingston 44-20-7943-1339
Royal Hospital for Sick Children *Recruiting*
Glasgow, Scotland, G3 8SJ
United Kingdom
Recruiting E.M. Simpson 44-141-201-0000
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Kathy Pritchard-Jones 44-20-8661-3496
Queen's Medical Centre *Recruiting*
Nottingham, England, NG7 2UH
United Kingdom
Recruiting David Walker 44-115-924-9924
Additional Information:
Study ID Numbers: CDR0000068961; SFOP-SIOP-MMT-98,SIOP-MMT-98,UKCCSG-SIOP-MMT-98,EU-20126
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025441
Other Osteosarcoma Studies:
1. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
2. Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
3. Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
4. Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
5. Irinotecan in Treating Children With Refractory Solid Tumors
Related Studies:
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Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
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