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A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390948
First Posted: July 11, 2011
Last Update Posted: October 9, 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):
Hoffmann-La Roche
Results First Submitted: September 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: High Grade Glioma
Interventions: Drug: Bevacizumab
Radiation: Radiotherapy
Drug: Temozolomide (TMZ)

  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
Chemoradiation + temozolomide (TMZ) and Chemoradiation + Bevacizumab + TMZ arms: 174 participants were screened; 121 were randomized; 116 received study treatment. Young Patient Cohort: 4 participants were screened; 3 were enrolled and received study treatment (these subjects were not randomized and are not included in efficacy analyses).

Reporting Groups
  Description
Chemoradiation + TMZ Participants received a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 milligrams per meter squared (mg/m^2) TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
Chemoradiation + Bevacizumab + TMZ Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks throughout the entire treatment period.
Bevacizumab + TMZ Young Patient Cohort (YPC) Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.

Participant Flow:   Overall Study
    Chemoradiation + TMZ   Chemoradiation + Bevacizumab + TMZ   Bevacizumab + TMZ Young Patient Cohort (YPC)
STARTED   59   62   3 
Treated   56   60   3 
COMPLETED   0   0   0 
NOT COMPLETED   59   62   3 
Alive in follow-up                20                17                1 
Death                30                34                2 
Ongoing                6                6                0 
Withdrew consent from survival follow-up                3                5                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
Chemoradiation + TMZ Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
Chemoradiation + Bevacizumab + TMZ Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
Bevacizumab + TMZ Young Patient Cohort (YPC) Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
Total Total of all reporting groups

Baseline Measures
   Chemoradiation + TMZ   Chemoradiation + Bevacizumab + TMZ   Bevacizumab + TMZ Young Patient Cohort (YPC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   62   3   124 
Age, Customized 
[Units: Participants]
       
< 3 years   0   0   3   3 
>/= 3 years and < 6 years   6   10   0   16 
>/= 6 years and < 13 years   30   35   0   65 
>/= 13 years and < 18 years   23   17   0   40 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      23  39.0%      28  45.2%      0   0.0%      51  41.1% 
Male      36  61.0%      34  54.8%      3 100.0%      73  58.9% 


  Outcome Measures
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1.  Primary:   Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)   [ Time Frame: From the time of randomization to the date of any defined event (up to approximately 52 months) ]

2.  Secondary:   Overall Survival   [ Time Frame: From the time of randomization to the date of death (up to approximately 52 months) ]

3.  Secondary:   Percentage of Participants With 1-Year Survival   [ Time Frame: 1 year ]

4.  Secondary:   Percentage of Participants With EFS as Determined by the CRRC at 6 Months   [ Time Frame: 6 months ]

5.  Secondary:   Percentage of Participants With EFS as Determined by the CRRC at 1 Year   [ Time Frame: 1 year ]

6.  Secondary:   EFS as Assessed by the Investigator   [ Time Frame: From the time of randomization to the date of any defined event (up to approximately 52 months) ]

7.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months) ]

8.  Secondary:   Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival   [ Time Frame: From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months) ]

9.  Secondary:   Health Status as Measured by the Health Utility Index (HUI)   [ Time Frame: Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up) ]

10.  Secondary:   Neurological Psychological Function as Measured by the Wechsler Scale   [ Time Frame: End of treatment (approximately 58 weeks post-baseline) ]

11.  Secondary:   Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations   [ Time Frame: From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months) ]

12.  Secondary:   Percentage of Participants With a Treatment Delay or Discontinuation   [ Time Frame: From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months) ]

13.  Secondary:   Number of Dose Administrations of Study Treatment in the Concurrent Phase   [ Time Frame: Beginning of the concurrent phase to end of treatment break (10 weeks) ]

14.  Secondary:   Percentage of Participants With an Adverse Event (AE)   [ Time Frame: From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months) ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 1-800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01390948     History of Changes
Other Study ID Numbers: BO25041
2010-022189-28 ( EudraCT Number )
ITCC-019 ( Other Identifier: Innovative Therapies for Children with Cancer Consortium (ITCC) )
HGG-01 ( Other Identifier: SIOP-E-Brain Tumour Group )
First Submitted: July 7, 2011
First Posted: July 11, 2011
Results First Submitted: September 1, 2016
Results First Posted: August 4, 2017
Last Update Posted: October 9, 2017