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Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas

This study has been completed.
Sponsor:
Collaborators:
Novartis
Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Information provided by (Responsible Party):
Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00782626
First received: October 29, 2008
Last updated: December 30, 2015
Last verified: December 2015
Results First Received: December 30, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioma
Low-grade Glioma
Astrocytoma
Intervention: Drug: everolimus

  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
Pts enrolled from 9 institutions over a two-year period (9/2009-9/2011).

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
Everolimus Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).

Participant Flow:   Overall Study
    Everolimus
STARTED   23 
COMPLETED   16 
NOT COMPLETED   7 
Adverse Event                1 
Progressive Disease                5 
Other Complicating Disease                1 



  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
Everolimus Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).

Baseline Measures
   Everolimus 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age [1] 
[Units: Participants]
 
<=18 years   23 
Between 18 and 65 years   0 
>=65 years   0 
[1] The analysis dataset is comprised of all eligible and treated patients.
Age 
[Units: Years]
Median (Full Range)
 9 
 (3 to 17) 
Gender 
[Units: Participants]
 
Female   17 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures

1.  Primary:   Overall Response   [ Time Frame: Disease evaluations (MRI brain, including volumetric analysis) occurred at baseline, at the end of course 1, every 3 courses during treatment up to 12 courses and at early treatment discontinuation. ]


  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: Mark Kieran
Organization: Dana-Farber Cancer Institute
phone: (617) 632-4907
e-mail: mark_kieran@dfci.harvard.edu



Responsible Party: Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00782626     History of Changes
Other Study ID Numbers: 09-001
Study First Received: October 29, 2008
Results First Received: December 30, 2015
Last Updated: December 30, 2015
Health Authority: United States: Food and Drug Administration