Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00516295
First received: August 14, 2007
Last updated: August 20, 2014
Last verified: July 2014
Results First Received: December 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ewing Sarcoma of Bone
Extraosseous Ewing Sarcoma
Peripheral Primitive Neuroectodermal Tumor
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Interventions: Drug: topotecan hydrochloride
Drug: vincristine sulfate
Drug: cyclophosphamide
Biological: bevacizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Feasibility Assessment of VTCB)

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Arm II (VTCB) Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
Arm III (CTC) Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.

Participant Flow:   Overall Study
    Arm I (Feasibility Assessment of VTCB)     Arm II (VTCB)     Arm III (CTC)  
STARTED     7     0     0  
COMPLETED     4     0     0  
NOT COMPLETED     3     0     0  
Lack of Efficacy                 2                 0                 0  
Ineligible                 1                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Arm I (Feasibility Assessment of VTCB)

Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.

topotecan hydrochloride: Given IV

vincristine sulfate: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Arm II (VTCB) Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I
Arm III (VTC) Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
Total Total of all reporting groups

Baseline Measures
    Arm I (Feasibility Assessment of VTCB)     Arm II (VTCB)     Arm III (VTC)     Total  
Number of Participants  
[units: participants]
  7     0     0     7  
Age  
[units: years]
Median ( Full Range )
  15  
  ( 12 to 20 )  
   
   
   
   
  15  
  ( 12 to 20 )  
Gender  
[units: participants]
       
Female     2             2  
Male     5             5  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0             0  
Asian     0             0  
Native Hawaiian or Other Pacific Islander     0             0  
Black or African American     0             0  
White     6             6  
More than one race     0             0  
Unknown or Not Reported     1             1  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2             2  
Not Hispanic or Latino     5             5  
Unknown or Not Reported     0             0  
Region of Enrollment  
[units: participants]
       
United States     7             7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.   [ Time Frame: First 2 courses (42 days) of therapy ]

2.  Primary:   Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab   [ Time Frame: Maximum of 5 years after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
In preparing to re-open for randomized enrollment in November, 2008 the study committee was asked to amend the study and the decision was made to close AEWS0521 for administrative purpose.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00516295     History of Changes
Other Study ID Numbers: NCI-2009-00369, NCI-2009-00369, AEWS0521, AEWS0521, U10CA098543
Study First Received: August 14, 2007
Results First Received: December 18, 2013
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration