Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00357396
First received: July 26, 2006
Last updated: October 22, 2015
Last verified: October 2015
Results First Received: October 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoma
Interventions: Biological: graft versus host disease prophylaxis/therapy
Drug: busulfan
Drug: melphalan
Drug: thiotepa
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

  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
Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
Related Donors Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant

Participant Flow:   Overall Study
    Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR     Related Donors  
STARTED     6     4  
COMPLETED     5     4  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  



  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
Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
Related Donors Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
Total Total of all reporting groups

Baseline Measures
    Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR     Related Donors     Total  
Number of Participants  
[units: participants]
  6     4     10  
Age  
[units: participants]
     
<=18 years     3     1     4  
Between 18 and 65 years     3     3     6  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     0     2  
Male     4     4     8  



  Outcome Measures

1.  Primary:   Overall Objective Response   [ Time Frame: 2 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Susan Prockop
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-6715
e-mail: prockops@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00357396     History of Changes
Other Study ID Numbers: 05-059
MSKCC-05059
Study First Received: July 26, 2006
Results First Received: October 22, 2015
Last Updated: October 22, 2015
Health Authority: United States: Institutional Review Board