A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
|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.|
|ClinicalTrials.gov Identifier: NCT01280552|
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : October 7, 2014
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Biological: ICT-107 Biological: Placebo DC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation|
|Study Start Date :||January 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2015|
Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
Autologous dendritic cells pulsed with immunogenic antigens
Placebo Comparator: Control
Autologous dendritic cells that have not been pulsed with antigens
Biological: Placebo DC
Autologous dendritic cells (DC) that have not been pulsed with antigens
- Overall Survival (OS) [ Time Frame: 2 -3 years ]The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis
- Overall Survival in HLA-A2 Patients [ Time Frame: 2-3 years ]Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
- PFS [ Time Frame: 2-3 years ]
- PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed.
- Population is all randomized patients ITT.
- Progression Free Survival in HLA- A2 Patients [ Time Frame: 2-3 yers ]
Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype.
Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280552
Show 25 Study Locations
|Study Director:||Anthony Gringeri, Ph.D.||ImmunoCellular Therapeutics, Ltd.|