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Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004146
First received: December 10, 1999
Last updated: May 5, 2015
Last verified: April 2015
Results First Received: March 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Interventions: Radiation: radiation therapy
Drug: carboxyamidotriazole
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
Between March and October of 2000 55 patients(pts) were accrued from outpatient clinics throughout ABTC(Adult Brain Tumor Consortium) consortium clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
pts had to have confirmed GBM (Glioblastoma) and be untreated except for biopsy or surgery and corticosteroids.

Reporting Groups
  Description
CAI With RT - Arm 1

CAI with RT

carboxyamidotriazole :

CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival

radiation therapy :


Participant Flow:   Overall Study
    CAI With RT - Arm 1
STARTED   55 
COMPLETED   55 
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
CAI With RT - Arm 1

CAI with RT

carboxyamidotriazole :

CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival

radiation therapy :


Baseline Measures
   CAI With RT - Arm 1 
Overall Participants Analyzed 
[Units: Participants]
 55 
Age, Customized 
[Units: Years]
Median (Full Range)
 59 
 (31.0 to 79.4) 
Gender 
[Units: Participants]
 
Female   22 
Male   33 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   54 
More than one race   0 
Unknown or Not Reported   0 
Karnofsky Performance Status [1] 
[Units: Participants]
 
Performance Status 100   9 
Performance Status 90   24 
Performance Status 80   10 
Performance Status 70   10 
Performance Status 60   2 
[1] performance status is an attempt to quantify patients' general well-being and activities of daily life. The scale is in intervals of 10. 100 being normal and 0 dead. For ABTC studies you had to have a KPS of at least 60 (Requires occasional assistance, but is able to care for most of his personal needs) to be eligible for the study.


  Outcome Measures
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1.  Primary:   Overall Survival Rate   [ Time Frame: approximately 30 months ]

2.  Primary:   Toxicity of CAI When Combined With RT   [ Time Frame: pts were reviewed for toxicity while on treatement - median time of 2 months ]

3.  Primary:   Correlation Between PK CAI and Toxicity in This pt Population   [ Time Frame: during treatment ]


  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: Stuart A Grossman
Organization: Adult Brain Tumor Consortium
phone: 410-955-3657
e-mail: jfisher@jhmi.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004146     History of Changes
Other Study ID Numbers: NCI-2012-03011
NCI-2012-03011 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR67378
NABTT-9904 ( Other Identifier: New Approaches to Brain Tumor Therapy Consortium )
NABTT-9904 ( Other Identifier: CTEP )
U01CA062475 ( US NIH Grant/Contract Award Number )
Study First Received: December 10, 1999
Results First Received: March 13, 2015
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration