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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 is ongoing, but not recruiting participants.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002466
  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
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

Genetics Home Reference related topics:   Soft Tissue Sarcoma  

MedlinePlus related topics:   Bone Cancer   Cancer   Kidney Cancer   Soft Tissue Sarcoma   Wilms' Tumor  

ChemIDplus related topics:   Doxorubicin   Doxorubicin hydrochloride   Ifosfamide   Cyclophosphamide   Etoposide   Vincristine   Etoposide phosphate   Vincristine sulfate  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   May 1990

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
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Kushner BH, LaQuaglia MP, Wollner N, Meyers PA, Lindsley KL, Ghavimi F, Merchant TE, Boulad F, Cheung NK, Bonilla MA, Crouch G, Kelleher JF Jr, Steinherz PG, Gerald WL. Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy. J Clin Oncol. 1996 May;14(5):1526-31.
 
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.
Kushner BH, Meyers PA, Gerald WL, Healey JH, La Quaglia MP, Boland P, Wollner N, Casper ES, Aledo A, Heller G, et al. Very-high-dose short-term chemotherapy for poor-risk peripheral primitive neuroectodermal tumors, including Ewing's sarcoma, in children and young adults. J Clin Oncol. 1995 Nov;13(11):2796-804.
 
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.

Study ID Numbers:   CDR0000076464, MSKCC-90062, NYU-97-6, NCI-V90-0126
First Received:   November 1, 1999
Last Updated:   June 21, 2008
ClinicalTrials.gov Identifier:   NCT00002466
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Bone Neoplasms
Ewing's family of tumors
Malignant mesenchymal tumor
Bone neoplasms
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Kidney cancer
Etoposide phosphate
Osteogenic sarcoma
Soft tissue sarcomas
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Wilms Tumor
Neuroepithelioma
Kidney Diseases

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Neoplasms, Bone Tissue
Urologic Diseases
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on July 03, 2008




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