Trial record 1 of 1 for:    ict-107
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A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov Identifier:
NCT01280552
First received: January 19, 2011
Last updated: October 16, 2014
Last verified: October 2014
Results First Received: October 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Biological: ICT-107
Biological: Placebo DC

  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
No text entered.

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
ICT-107

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Placebo

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens


Participant Flow:   Overall Study
    ICT-107     Placebo  
STARTED     81     43  
COMPLETED     75 [1]   42  
NOT COMPLETED     6     1  
[1] Survival is still being assessed



  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
ICT-107

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Placebo

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

Total Total of all reporting groups

Baseline Measures
    ICT-107     Placebo     Total  
Number of Participants  
[units: participants]
  81     43     124  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     59     29     88  
>=65 years     22     14     36  
Gender  
[units: participants]
     
Female     37     12     49  
Male     44     31     75  
Region of Enrollment  
[units: participants]
     
United States     81     43     124  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: 2 -3 years ]

2.  Primary:   Overall Survival in HLA-A2 Patients   [ Time Frame: 2-3 years ]

3.  Secondary:   PFS   [ Time Frame: 2-3 years ]

4.  Secondary:   Progression Free Survival in HLA- A2 Patients   [ Time Frame: 2-3 yers ]


  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: Anthony Gringeri, Ph.D. Senior Vice President Strategic Resources
Organization: ImmunoCellular Therapeutics Ltd.
phone: 818 264 2300
e-mail: anthony.gringeri@imuc.com


No publications provided


Responsible Party: ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT01280552     History of Changes
Other Study ID Numbers: ICT-107-201
Study First Received: January 19, 2011
Results First Received: October 2, 2014
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration