A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)
This Phase III trial is designed to evaluate the impact on disease progression and survival
time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy
treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white
blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is
the starter engine of the immune system. The white cells are then made into dendritic cells
and they are educated to "teach" the immune system how to recognize brain cancer cells.
Eligible patients will receive a series of injections of DCVax-L, to activate and then boost
the immune response to the tumor cells.
The primary study endpoint is PFS (progression free survival), and the first secondary
endpoint is overall survival (OS). Other endpoints include performance status, immune
response, and also safety. Interim analyses to assess efficacy are incorporated in the trial
design.
Side effects reported from early trials are mostly mild, and may include skin reactions of
redness, pain & swelling at the injection site.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients.
Time to tumor progression or death
No
Linda Liau, M.D.
Principal Investigator
University of California, Los Angeles
United States: Food and Drug Administration
020221
NCT00045968
December 2006
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Henry Ford Hospital | Detroit, Michigan 48202 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
North Shore University Hospital | Manhasset, New York 11030 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
University of Rochester Medical Center | Rochester, New York 14642 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Winthrop University Hospital | Mineola, New York 11501 |
University of Illinois Medical Center | Chicago, Illinois 60612 |
City of Hope | Duarte, California 91010 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Georgetown University Medical Center | Washington, District of Columbia 20007 |
UCLA | Los Angeles, California 90095 |
UCI Medical Center | Irvine, California 92868 |
UCSD Moores Cancer Center | La Jolla, California 93093 |
Sutter Institute for Medical Research | Sacramento, California 95816 |
South Pasadena Cancer Center | South Pasadena, California 91030 |
Mount Sinai CCOP | Miami Beach, Florida 33140 |
Illinois Cancer Care | Peoria, Illinois 61615 |
IU Simon Cancer Center | Indianapolis, Indiana 46202 |
Tufts Medical Center | Boston, Massachusetts 02111 |
University of Michigan, Department of Neurosurgery | Ann Arbor, Michigan 48109 |
St. Luke's Hospital | Kansas City, Missouri 64111 |
John Theurer Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Long Island Brain Tumor Centre at Neurological Surgery P.C. | Commack, Great Neck, New York 11021 |
Huntington Hospital | Huntington, New York 11743 |
New York University Clinical Cancer Center | New York, New York 10016 |
South Nassau Community Hospital | Oceanside, New York 11572 |
Mercy Medical Center | Rockville Centre, New York 11571-9024 |
Brain and Spine Surgeons of New York and Northern Westchester Hospital | White Plains, New York 10604 |
UC Cancer Institute | Cincinnati, Ohio 45267 |
Medical University of South Carolina Hospitals and Clinics | Charleston, South Carolina 29425 |
St. Thomas Hospital | Nashville, Tennessee 37205 |
Vanderbilt Ingram Cancer Center | Nashville, Tennessee 37232 |
Baylor Research Institute | Dallas, Texas 75246 |
Swedish Hospital Neuroscience Research | Seattle, Washington 98122 |
Columbia University Medical Center | New York, New York 10032 |
St. Joseph Hospital of Orange | Orange, California 92868 |
John Nasseff Neuroscience Institute | Minneapolis, Minnesota 55407 |
Yvonne Kew, MD, PhD, Neuro-Oncology Clinic | Houston, Texas 77030 |
Cancer Therapy & Research at University of Texas Health Science Center San Antonio | San Antonio, Texas 78229 |