Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049127
First received: November 12, 2002
Last updated: October 1, 2014
Last verified: August 2014
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Anaplastic Oligodendroglioma
Adult Mixed Glioma
Adult Oligodendroglioma
Recurrent Adult Brain Tumor
Interventions: Drug: imatinib mesylate
Other: laboratory biomarker analysis
Other: pharmacological study

  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
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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
Study 1 Arm C

Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens

Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses.

Study 2 Arm A

Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens

Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily

Study 2 Arm B

Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens

Imatinib at 300 mg b.i.d.

Study 3 Arm D

Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens

Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily

Study 3 Arm E

Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens

Imatinib at 300 mg b.i.d.


Participant Flow:   Overall Study
    Study 1 Arm C     Study 2 Arm A     Study 2 Arm B     Study 3 Arm D     Study 3 Arm E  
STARTED     12     0     40     0     12  
COMPLETED     12     0     39     0     12  
NOT COMPLETED     0     0     1     0     0  
Withdrawal by Subject                 0                 0                 1                 0                 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.
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Reporting Groups
  Description
Study 1 Arm C Phase I patients on EIACs and <=2 prior regimens
Study 2 Arm A Phase II patients on EIACs and <=2 prior regimens
Study 2 Arm B Phase II patients not on EIACs and <=2 prior regimens
Study 3 Arm D Phase II patients on EIACs and >2 prior regimens
Study 3 Arm E Phase II patients not on EIACs and >2 prior regimens
Total Total of all reporting groups

Baseline Measures
    Study 1 Arm C     Study 2 Arm A     Study 2 Arm B     Study 3 Arm D     Study 3 Arm E     Total  
Number of Participants  
[units: participants]
  12     0     39     0     12     63  
Age  
[units: years]
Median ( Full Range )
           
participants     45  
  ( 34 to 65 )  
   
   
  46  
  ( 22 to 83 )  
   
   
  47  
  ( 22 to 59 )  
  46  
  ( 22 to 83 )  
Gender  
[units: participants]
           
Female     1         17         4     22  
Male     11         22         8     41  
Study-Specific Measure [1]
[units: participants]
           
0     7         10         6     23  
1     4         23         4     31  
2     1         6         2     9  
[1]

Eastern Cooperative Oncology Group (ECOG) PERFORMANCE STATUS:

  • 0=Asymptomatic and fully active
  • 1=Symptomatic; fully ambulatory; restricted in physically strenuous activity
  • 2=Symptomatic; ambulatory; capable of self-care; more than 50% of waking hours are spent out of bed
  • 3=Symptomatic; limited self-care; spends more than 50% of time in bed, but not bedridden
  • 4=Completely disabled; no self-care; bedridden



  Outcome Measures
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1.  Primary:   6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.   [ Time Frame: 6 months ]

2.  Secondary:   Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).   [ Time Frame: Up to 5 years ]

3.  Secondary:   Percentage of Patients Progression-free   [ Time Frame: Time from study registration to date of disease progression or last follow-up, assessed up to 5 years ]

4.  Secondary:   Overall Time to Death   [ Time Frame: Time from date of registration to date of death due to any cause or last follow-up, assessed 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: Kurt A. Jaeckle, M.D.
Organization: Mayo Clinic
phone: 5072841370
e-mail: jaecle.kurt@mayo.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049127     History of Changes
Other Study ID Numbers: NCI-2011-01576, NCI-2011-01576, NCCTG-N0272, CDR0000257812, N0272, N0272, U10CA025224
Study First Received: November 12, 2002
Results First Received: November 25, 2013
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration