A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): ICT-107; Placebo DC
Intervention type(s): Biological; Biological
Intervention description(s): Autologous dendritic cells pulsed with immunogenic antigens; Autologous dendritic cells (DC) that have not been pulsed with antigens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Glioblastoma Multiforme