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Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00424554
First received: January 18, 2007
Last updated: July 18, 2012
Last verified: June 2011
History of Changes
Results First Received: June 3, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glioma
Intervention: Drug: temozolomide

  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
Temozolomide (TMZ)

Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.

As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.
No Intervention No pre-surgery treatment with temozolomide

Participant Flow:   Overall Study
    Temozolomide (TMZ)     No Intervention  
STARTED     34     6  
COMPLETED     34     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Temozolomide (TMZ)

Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.

As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.
No Intervention No pre-surgery treatment with temozolomide
Total Total of all reporting groups

Baseline Measures
    Temozolomide (TMZ)     No Intervention     Total  
Number of Participants  
[units: participants]
 		  34     6     40  
Age, Customized [1]
[units: Participants]
 		  34     6     40  
Gender  
[units: participants]
 		     
Female     17     4     21  
Male     17     2     19  
Region of Enrollment  
[units: participants]
 		     
Canada     34     6     40  
[1] Age range: 18-75 years



  Outcome Measures
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1.  Primary:   MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery   [ Time Frame: 14 days ]
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2.  Secondary:   Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities   [ Time Frame: 12 months ]
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3.  Secondary:   Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)   [ Time Frame: 12 months ]
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4.  Secondary:   Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor   [ Time Frame: 14 days ]
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5.  Secondary:   MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels   [ Time Frame: 14 days ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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

The assay developed to measure MGMT activity had high variability.

The TMZ assay was unable to detect the low levels of the drug due to the relatively low dose and short half life of TMZ.

 


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00424554     History of Changes
Other Study ID Numbers: P04602
Study First Received: January 18, 2007
Results First Received: June 3, 2011
Last Updated: July 18, 2012
Health Authority: Canada: Health Canada