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Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (Poly-ICLC)

This study has been terminated.
(prematurely discontinued after results of the EORTC phase-3 study defined the SOC for newly diagnosed GMB pts as RT plus concomitant and adjuvant TMZ)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052715
First Posted: January 27, 2003
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
Results First Submitted: January 26, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Intervention: Drug: poly ICLC

  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
Patients enrolled from 7/14/2003 through 12/19/2005. Patients recruited from outpatient clinic centers.

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
Poly-ICLC

poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri

Poly-ICLC drug

poly ICLC


Participant Flow:   Overall Study
    Poly-ICLC
STARTED   31 
COMPLETED   30 
NOT COMPLETED   1 
wrong histology                1 



  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
Poly-ICLC

poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri

Poly-ICLC drug

poly ICLC


Baseline Measures
   Poly-ICLC 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 53 
 (26 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      16  53.3% 
Male      14  46.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   3.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   3.3% 
White      27  90.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1   3.3% 
Karnofsky Performance Status Scale [1] 
[Units: Units on a scale]
Median (Full Range)
 90 
 (60 to 100) 
[1] Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
Histology Glioblastoma [1] 
[Units: Participants]
 30 
[1] WHO Classification
Extent of Resection 
[Units: Participants]
Count of Participants
 
Biopsy      2   6.7% 
Subtotal resection      17  56.7% 
Gross Total resection      11  36.7% 


  Outcome Measures
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1.  Primary:   Overall Survival in Pts With Newly Diagnosed GBM   [ Time Frame: total survival from surgical diagnosis ]

2.  Secondary:   To Determine 6 Months Progression Free Survival   [ Time Frame: 6 months ]

3.  Secondary:   Determine the 12-month Survival Rate   [ Time Frame: 1 year ]

4.  Secondary:   to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients   [ Time Frame: 2 years ]

5.  Secondary:   To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   To Determine Tumor Response   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Enrollment was prematurely discontinued after the results of the EORTC phase-3 study defined the standard of care for newly diagnosed glioblastoma patients as radiotherapy plus concomitant and adjuvant temozolomide


  More Information
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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.


Results Point of Contact:  
Name/Title: Michael Prados, MD
Organization: North American Brain Tumor Consortium
phone: 410-955-8837
e-mail: jfisher@jhmi.edu


Publications of Results:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00052715     History of Changes
Other Study ID Numbers: NABTC-0105
CDR0000258685 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02506 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: January 24, 2003
First Posted: January 27, 2003
Results First Submitted: January 26, 2017
Results First Posted: March 16, 2017
Last Update Posted: March 16, 2017