Study:
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
Rationale:
n/a
Purpose:
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.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Glioblastoma Multiforme |
Biological: ICT-107
Biological: Placebo DC |
Phase 2 |
Verified by
ImmunoCellular Therapeutics, Ltd.
October, 2012
Sponsored by: ImmunoCellular Therapeutics, Ltd.
Information provided by: ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov identifier: NCT01280552
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
Cleveland, Ohio 44195
United States
n/a