Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00061893
First received: June 5, 2003
Last updated: February 7, 2013
Last verified: January 2013
Results First Received: January 17, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoma
Interventions: Drug: celecoxib
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: vinblastine sulfate
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Combination Chemotherapy Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.

Participant Flow:   Overall Study
    Combination Chemotherapy  
STARTED     38  
COMPLETED     20  
NOT COMPLETED     18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Combination Chemotherapy Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.

Baseline Measures
    Combination Chemotherapy  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Mean ± Standard Deviation
  12.97  ± 5.81  
Gender  
[units: participants]
 
Female     15  
Male     23  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     5  
Not Hispanic or Latino     31  
Unknown or Not Reported     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     1  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     0  
White     30  
More than one race     0  
Unknown or Not Reported     5  
Region of Enrollment  
[units: participants]
 
United States     34  
Puerto Rico     0  
Canada     4  
Australia     0  



  Outcome Measures
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1.  Primary:   Occurrence of Severe Toxicity   [ Time Frame: Duration of Protocol Therapy ]

2.  Secondary:   Event Free Survival   [ Time Frame: 24 months after start of protocol therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications of Results:

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00061893     History of Changes
Other Study ID Numbers: AEWS02P1, CDR0000302409
Study First Received: June 5, 2003
Results First Received: January 17, 2013
Last Updated: February 7, 2013
Health Authority: United States: Federal Government