O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00275002
First received: January 10, 2006
Last updated: February 27, 2013
Last verified: February 2013
Results First Received: July 13, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Interventions: Drug: O6-benzylguanine
Drug: temozolomide

  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
Participants from PBTC member institutions were enrolled between October 2005 and February 2008.

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
Recurrent High-Grade Gliomas Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
Recurrent Brain Stem Tumors Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.

Participant Flow:   Overall Study
    Recurrent High-Grade Gliomas     Recurrent Brain Stem Tumors  
STARTED     25     16  
COMPLETED     3     0  
NOT COMPLETED     22     16  
Death                 1                 0  
Disease progression                 21                 15  
Adverse Event                 0                 1  



  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
Recurrent High-Grade Gliomas Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
Recurrent Brain Stem Tumors Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Recurrent High-Grade Gliomas     Recurrent Brain Stem Tumors     Total  
Number of Participants  
[units: participants]
  25     16     41  
Age  
[units: participants]
     
<=18 years     23     16     39  
Between 18 and 65 years     2     0     2  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  13.4  ± 5.1     7.8  ± 3.9     11.2  ± 5.4  
Gender  
[units: participants]
     
Female     9     12     21  
Male     16     4     20  
Region of Enrollment  
[units: participants]
     
United States     25     16     41  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With an Objective Response (Complete Response or Partial Response)   [ Time Frame: Week 8, 16, 24, 32, and 40 after starting therapy ]

2.  Secondary:   Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide   [ Time Frame: From day 1 of therapy up to 49 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dana Wallace
Organization: Pediatric Brain Tumor Consortium
phone: 901-595-2617
e-mail: dana.wallace@stjude.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00275002     History of Changes
Obsolete Identifiers: NCT00291291
Other Study ID Numbers: NCI-2012-03050, PBTC-015, NCI-06-C-0089, NCI-P6692, CDR0000455561
Study First Received: January 10, 2006
Results First Received: July 13, 2011
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration