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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall survival (OS)
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)
2 -3 years
No
United States: Food and Drug Administration
ICT-107-201
NCT01280552
January 2011
Name | Location |
---|---|
Wake Forest University | Winston-Salem, North Carolina 27103 |
Arizona Cancer Center | Tucson, Arizona 85724 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
University of Texas Health Science Center at Houston | Houston, Texas 77225 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Johns Hopkins University School of Medicine | Baltimore, Maryland 21205 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Penn State Hershey Medical Center | Hershey, Pennsylvania 17033 |
University of Virginia Health System | Charlottesville, Virginia 22903 |
NYU Clinical Cancer Center | New York, New York 10016 |
University of Alabama at Birbingham School of Medicine | South Birmingham, Alabama 35294 |
UC San Diego Moores Cancer Center | La Jolla, California 92093 |
Jewish Hospital Medical Center | Louisville, Kentucky 40245 |
Massachusetss General Hospital | Boston, Massachusetts 02114 |
New Jersey Neuroscience Institute | Edison, New Jersey 08818 |
The Long Island Brain Tumor Center at Neurological Surgery, PC | Great Neck, New York 11021 |
Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center | Cleveland, Ohio 44195 |
Sammons Cancer Center (Baylor) | Dallas, Texas 75246 |
Weil Cornell Medical College | New York, New York 10065 |