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Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01222715
First Posted: October 18, 2010
Last Update Posted: May 5, 2017
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 (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: January 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Pleomorphic Rhabdomyosarcoma
Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Childhood Rhabdomyosarcoma
Interventions: Biological: Bevacizumab
Drug: Cyclophosphamide
Other: Laboratory Biomarker Analysis
Drug: Temsirolimus
Drug: Vinorelbine Tartrate

  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
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
Regimen A The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
Regimen B The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.

Participant Flow:   Overall Study
    Regimen A   Regimen B
STARTED   44   43 
COMPLETED   8   16 
NOT COMPLETED   36   27 
Adverse Event                0                4 
Death                0                1 
Lack of Efficacy                22                14 
Physician Decision                12                2 
Refusal of further protocol therapy                0                4 
Pt cannot receive treatment for >9 wks                1                1 
Ineligible                0                1 
Surgery or radiation therapy in 1st 6 wk                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.
No text entered.

Reporting Groups
  Description
Regimen A The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
Regimen B The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
Total Total of all reporting groups

Baseline Measures
   Regimen A   Regimen B   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   43   87 
Age 
[Units: Months]
Mean (Standard Deviation)
 116.35  (72.82)   140.65  (75.93)   128.36  (74.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  50.0%      20  46.5%      42  48.3% 
Male      22  50.0%      23  53.5%      45  51.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      9  20.5%      10  23.3%      19  21.8% 
Not Hispanic or Latino      35  79.5%      31  72.1%      66  75.9% 
Unknown or Not Reported      0   0.0%      2   4.7%      2   2.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   2.3%      1   2.3%      2   2.3% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      1   2.3%      1   2.3%      2   2.3% 
Black or African American      7  15.9%      7  16.3%      14  16.1% 
White      30  68.2%      27  62.8%      57  65.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      5  11.4%      7  16.3%      12  13.8% 


  Outcome Measures
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1.  Primary:   Event Free Survival Probability   [ Time Frame: 1 year ]

2.  Primary:   Rate of Dose-Limiting Toxicities   [ Time Frame: From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities. ]

3.  Secondary:   Response Rate (CR + PR)   [ Time Frame: From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities. ]

4.  Other Pre-specified:   Biomarker Levels   [ Time Frame: Up to 36 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment   [ Time Frame: Baseline up to day 42 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Clinical Response   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response   [ Time Frame: Up to 36 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Progression-free Survival   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01222715     History of Changes
Other Study ID Numbers: NCI-2011-02607
NCI-2011-02607 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST0921
CDR0000687113
ARST0921
ARST0921 ( Other Identifier: Childrens Oncology Group )
ARST0921 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2010
First Posted: October 18, 2010
Results First Submitted: January 9, 2017
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017