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Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002466
First Posted: April 26, 2004
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Memorial Sloan Kettering Cancer Center
  Purpose

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.


Condition Intervention Phase
Kidney Cancer Sarcoma Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: May 1990
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002466


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Study Chair: Brian H. Kushner, MD Memorial Sloan Kettering Cancer Center
  More Information

Publications:
Kushner BH, LaQuaglia MP, Wollner N, et al.: Desmoplastic small cell tumor (DSCT): prolonged progression-free survival with aggressive multi-modality therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1414, 443, 1995.
Meyers PA, Gardner S, Lindsley K, et al.: High-risk Ewing's sarcoma (ES)/primitive neuroectodermal tumor (PNET) of bone: consolidation with total body irradiation (TBI), melphalan, and autologous stem cell reconstitution. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1447, 451, 1995.
Kushner BH, Meyers PA, Cheung NK, et al.: Very high-dose short-term chemotherapy for poor-risk solid tumors in children and young adults. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1416, 413, 1993.

ClinicalTrials.gov Identifier: NCT00002466     History of Changes
Other Study ID Numbers: 90-062
CDR0000076464 ( Registry Identifier: PDQ (Physician Data Query) )
NYU-97-6
NCI-V90-0126
First Submitted: November 1, 1999
First Posted: April 26, 2004
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
localized osteosarcoma
metastatic osteosarcoma
stage III adult soft tissue sarcoma
stage III Wilms tumor
stage IV Wilms tumor
nonmetastatic childhood soft tissue sarcoma
metastatic childhood soft tissue sarcoma
childhood desmoplastic small round cell tumor
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
stage IV adult soft tissue sarcoma
Askin tumor
peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Sarcoma
Kidney Neoplasms
Carcinoma, Renal Cell
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Wilms Tumor
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Cyclophosphamide
Ifosfamide