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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | May 1990 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002466 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer | ||||
| Official Title ICMJE | Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Ifosfamide, Followed by Resection and Radiotherapy in Patients With Peripheral Primitive Neuroectodermal Tumors or Ewing's Sarcoma | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer. |
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| Detailed Description | OBJECTIVES: I. Determine the response rate and event-free survival of patients with peripheral primitive neuroectodermal tumors or Ewing's sarcoma treated with cyclophosphamide, doxorubicin, vincristine, etoposide, and ifosfamide, followed by surgery (if feasible) and radiotherapy. II. Determine the response to a uniform treatment regimen in order to clarify whether these disease categories each have a different prognosis. OUTLINE: Patients are stratified according to disease category (primitive neuroectodermal tumor vs Ewing's sarcoma). Patients receive treatment on regimen A as outlined below during courses 1-3 and 6 and regimen B as outlined below during courses 4, 5, and 7 in the absence of disease progression or unacceptable toxicity. Each course lasts 3-4 weeks. Patients without metastatic disease after completion of course 3 undergo complete tumor resection, if feasible. Patients achieving complete response with or without microscopic residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3 weeks. Patients with gross residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3.6 weeks. Regimens A and B are defined below: Regimen A: Patients receive cyclophosphamide IV over 6 hours on days 1 and 2, doxorubicin IV continuously and vincristine IV continuously on days 1-3, and vincristine IV on day 9. Regimen B: Patients receive etoposide IV over 1 hour, followed immediately by ifosfamide IV over 1 hour on days 1-5. Patients are followed monthly for 18 months and then every 6 months for 18 months. PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study within 5 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Not specified |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002466 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000076464, MSKCC-90062, NYU-97-6, NCI-V90-0126 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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