Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01342757
First received: April 26, 2011
Last updated: May 13, 2014
Last verified: June 2013
Results First Received: May 3, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Adult Glioblastoma
Depression
Recurrent Adult Brain Tumor
Interventions: Drug: vorinostat
Drug: temozolomide
Procedure: magnetic resonance spectroscopic imaging
Other: survey administration

  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
Recruitment closed

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No events requiring changes in approach or enrollment criteria

Reporting Groups
  Description
Vorinostat and Temozolomide

Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.

Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.


Participant Flow:   Overall Study
    Vorinostat and Temozolomide  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     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
Arm I

Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.

Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.


Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 10  
Gender  
[units: participants]
 
Female     4  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Magnetic Resonance Spectroscopy Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index   [ Time Frame: 9 weeks ]

2.  Primary:   Measurable Change on Magnetic Resonance Spectroscopy Imaging After Vorinostat Administration   [ Time Frame: 9 weeks ]

3.  Primary:   Proportion of Patients Who Experience Metabolic Restoration Between the Responders and Non-responder Groups by MRS Scans   [ Time Frame: After 1 week ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Mean (or Median) Change in Metabolite Levels   [ Time Frame: Baseline to 1 week ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
In five of the twelve cases spectroscopic indices could not be calculated because the tumor volume was outside of reliably measured voxels. These were primarily accounted for by tumor closeness to the skull or the small size of residual tumor.


  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: Jeffrey J. Olson, MD
Organization: Emory University School of Medicine
phone: 404-778-3091
e-mail: jolson@emory.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01342757     History of Changes
Other Study ID Numbers: NCI-2011-02569, EMORY IRB #00044064, WCI-44064, R21CA141836
Study First Received: April 26, 2011
Results First Received: May 3, 2013
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration