Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01462695
First received: October 27, 2011
Last updated: August 18, 2015
Last verified: June 2015
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Childhood Cerebellar Anaplastic Astrocytoma
Childhood Cerebral Anaplastic Astrocytoma
Childhood Cerebral Astrocytoma
Childhood Infratentorial Ependymoma
Childhood Mixed Glioma
Childhood Oligodendroglioma
Childhood Supratentorial Ependymoma
Recurrent Childhood Cerebellar Astrocytoma
Recurrent Childhood Cerebral Astrocytoma
Recurrent Childhood Ependymoma
Recurrent Childhood Subependymal Giant Cell Astrocytoma
Interventions: Other: Diagnostic Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Sunitinib Malate

  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
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Reporting Groups
  Description
Stratum A: Recurrent High Grade Glioma

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given PO

diagnostic laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Stratum B: Recurrent Ependymoma

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given PO

diagnostic laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies


Participant Flow:   Overall Study
    Stratum A: Recurrent High Grade Glioma     Stratum B: Recurrent Ependymoma  
STARTED     17     13  
COMPLETED     0     0  
NOT COMPLETED     17     13  
Adverse Event                 1                 1  
Death                 2                 0  
Lack of Efficacy                 6                 12  
Physician Decision                 5                 0  
Withdrawal by Subject                 2                 0  
Inevaluable (did not receive study drug)                 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
Stratum A: Recurrent High Grade Glioma

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given PO

diagnostic laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Stratum B: Recurrent Ependymoma

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given PO

diagnostic laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Stratum A: Recurrent High Grade Glioma     Stratum B: Recurrent Ependymoma     Total  
Number of Participants  
[units: participants]
  17     13     30  
Age  
[units: years]
Median (Full Range)
  14.2   (4.7 to 19.9)     12.0   (3.0 to 16.9)     13.4   (3.0 to 19.9)  
Age  
[units: participants]
     
<=18 years     16     13     29  
Between 18 and 65 years     1     0     1  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     4     7     11  
Male     13     6     19  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     0     3  
White     14     11     25  
More than one race     0     0     0  
Unknown or Not Reported     0     2     2  
Region of Enrollment  
[units: participants]
     
United States     16     11     27  
Canada     1     0     1  
Australia     0     1     1  
Saudi Arabia     0     1     1  



  Outcome Measures

1.  Primary:   Sustained Objective Response Rate   [ Time Frame: Up to 5 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:  
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: NCT01462695     History of Changes
Other Study ID Numbers: NCI-2011-03536, NCI-2011-03536, CDR0000712861, COG-ACNS1021, ACNS1021, ACNS1021, U10CA098543
Study First Received: October 27, 2011
Results First Received: February 5, 2015
Last Updated: August 18, 2015
Health Authority: United States: Food and Drug Administration