PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL® Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence
PRECISE is a Phase III clinical trial of experimental drug IL13-PE38QQR (Study Drug).
IL13-PE38QQR is a tumor-targeting agent administered by a continuous infusion directly into
the brain around the cavity where the tumor has been removed. Through previous research,
this Study Drug has shown potential to control some of the recurrent malignant gliomas, such
as glioblastoma multiforme (GBM), anaplastic astrocytoma, and malignant mixed
oligoastrocytoma.
The Study Drug is made by combining a human protein (IL13) with a portion of a bacterial
toxin protein, Pseudomonas Exotoxin (PE). The IL13 portion binds to receptors on the tumor
like a "key to a lock," allowing the PE portion to enter and kill those cells. Since tumor
cells preferentially bind the drug, normal (healthy) brain cells are much less likely to be
damaged by the drug. The Study Drug is delivered through tubing or catheters placed directly
into the area surrounding the resection cavity. These catheters will be surgically placed
from 2-7 days after the tumor has been removed. A pump is then used to slowly push the drug
solution through the catheters using convection-enhanced delivery (CED) over a period of 4
days.
The GLIADEL® Wafer is an anti-cancer drug that is approved by the U.S. Food and Drug
Administration (FDA) and sold for the treatment of recurrent or newly diagnosed GBM.
Patients receiving GLIADEL® will have wafers placed at the time of surgery to remove tumor.
Eligible patients enrolled in the PRECISE trial will be randomly assigned to receive either
IL13-PE38QQR or GLIADEL® Wafer. Patients will have a 2 out of 3 chance to receive
IL13-PE38QQR and 1 out of 3 chance to receive GLIADEL® Wafer.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
IL13PEI-301-R03
NCT00076986
February 2004
March 2007
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Mayo Clinic | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Baptist Memorial Hospital | Memphis, Tennessee 38146 |
Evanston Northwestern Healthcare | Evanston, Illinois 60201 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
Emory University | Atlanta, Georgia 30322 |
The Johns Hopkins University | Baltimore, Maryland 21287 |
Henry Ford Health Systems | Detroit, Michigan 48202 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Texas M.D. Anderson Cancer Center | Houston, Texas 77030 |
St. Louis University | St. Louis, Missouri 63110 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |
University of Alabama at Birmingham - Division of Neurosurgery | Birmingham, Alabama 35294-3410 |
Los Angeles County/USC | Los Angeles, California 90033 |
University of California - Los Angeles Neuro-Oncology Program | Los Angeles, California 90095-1769 |
Cedars-Sinai Medical Center - Neurological Institute | Los Angeles, California 90048 |
University of California San Francisco - Dept. of Neurological Surgery | San Francisco, California 94143 |
University of Colorado Hospital - Anschutz Cancer Pavillion | Aurora, Colorado 80010 |
Yale University School of Medicine - Department of Neurosurgery | New Haven, Connecticut 06520 |
Florida Hospital Neuroscience Institute | Orlando, Florida 32804 |
Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery | Chicago, Illinois 60611 |
CINN at Rush Unversity Medical School | Chicago, Illinois 60612 |
Memorial Sloan Kettering Cancer Center Department of Neurology | New York, New York 10021 |
Weill Cornell Medical College - Department of Neurological Surgery | New York, New York 10021 |
Columbia University Medical Center - Neurological Institute | New York, New York 10032 |
Carolina Neurosurgery & Spine Assoc. | Charlotte, North Carolina 28204 |
Wake Forest University Health Sciences - Department of Neurosurgery | Winston-Salem, North Carolina 27157 |
Cleveland Clinic Foundation Department of Neurological Surgery | Cleveland, Ohio 44195 |
The Ohio State University Medical Center | Columbus, Ohio 43210 |
The Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Huntsman Cancer Insitute | Salt Lake City, Utah 84132 |
University of Virginia Health Systems - Department of Neurological Surgery | Charlottesville, Virginia 22908 |
Benaroya Research Institute at Virginia Mason Medical Center | Seattle, Washington 98101 |
West Virginia University Department of Neurosurgery | Morgantown, West Virginia 26506 |
University of Wisconsin Hospital and Clinic | Madison, Wisconsin 53792 |