A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.
Biological: Placebo DC
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Overall Survival (OS) [ Time Frame: 2 -3 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
- PFS [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
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
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
The proposed phase 2 study is a randomized, double blind, controlled study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemoradiation. The phase 1 clinical trial demonstrated safety and promising efficacy in a small, open-label study. The purpose of this study is to provide information from a larger, controlled clinical trial. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Patients will have had tumor resection, magnetic resonance imaging (MRI) and tumor assessment prior to enrollment into the study. Post surgical treatment consists of 6 weeks of chemotherapy (TMZ) and radiation followed by a washout period. After Screening and informed consent, patients will undergo apheresis at the study site for collection of peripheral blood mononuclear cells (PBMCs). Apheresis product will be sent to a central site where monocytes will be purified and cultured into dendritic cells (DC). DC will be pulsed with synthetic peptides that correspond to immunogenic epitopes of tumor antigens. The pulsed dendritic cells will then be aliquoted and frozen before shipping back to the site. Patients will have the autologous DCs reinfused intradermally. A control group will receive unpulsed autologous DC. Patients will be randomized by age in a 2:1 ratio to ICT-107 or control.Patients will receive at least four intradermal injections of the ICT-107 vaccine and additional vaccine during a maintenance phase. The primary objective is to compare overall survival (OS) and progression free survival (PFS) in patients when treated with ICT-107 versus Control.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280552
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|Study Director:||Anthony Gringeri, Ph.D.||ImmunoCellular Therapeutics, Ltd.|