Spots Global Cancer Trial Database for The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
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Trial Identification
Brief Title: The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
Official Title: 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
Study ID: NCT00076986
Conditions
Study Description
Brief Summary: The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham - Division of Neurosurgery, Birmingham, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
Los Angeles County/USC, Los Angeles, California, United States
Cedars-Sinai Medical Center - Neurological Institute, Los Angeles, California, United States
University of California - Los Angeles Neuro-Oncology Program, Los Angeles, California, United States
University of California San Francisco - Dept. of Neurological Surgery, San Francisco, California, United States
University of Colorado Hospital - Anschutz Cancer Pavillion, Aurora, Colorado, United States
Yale University School of Medicine - Department of Neurosurgery, New Haven, Connecticut, United States
Florida Hospital Neuroscience Institute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery, Chicago, Illinois, United States
CINN at Rush Unversity Medical School, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Evanston Northwestern Healthcare, Evanston, Illinois, United States
The Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health Systems, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
St. Louis University, St. Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center Department of Neurology, New York, New York, United States
Weill Cornell Medical College - Department of Neurological Surgery, New York, New York, United States
Columbia University Medical Center - Neurological Institute, New York, New York, United States
Carolina Neurosurgery & Spine Assoc., Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences - Department of Neurosurgery, Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation Department of Neurological Surgery, Cleveland, Ohio, United States
The Ohio State University Medical Center, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Baptist Memorial Hospital, Memphis, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Insitute, Salt Lake City, Utah, United States
University of Virginia Health Systems - Department of Neurological Surgery, Charlottesville, Virginia, United States
Benaroya Research Institute at Virginia Mason Medical Center, Seattle, Washington, United States
West Virginia University Department of Neurosurgery, Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinic, Madison, Wisconsin, United States
Calgary Health Region, Calgary, Alberta, Canada
Walter MacKenzie Health Sciences Center, Edmonton, Alberta, Canada
Cancer Care Manitoba, Winnepeg, Manitoba, Canada
London Regional Cancer Center, London, Ontario, Canada
Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada
Royal University Hospital, Saskatoon, Saskatchewan, Canada
Toronto Western Hospital Division of Neurosurgery, Toronto, , Canada
Techniche Universität Dresden Klinik und Poliklinik für Neurochirurgie, Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf - Klinik für Neurochirurgie, Hamburg, , Germany
Klinikum der Universität Heidelberg, Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein - Klinik für Neurochirurgie, Kiel, , Germany
Ludwig-Maximilians-Universität München - Klinikum Großhadern - Neurochirurgische Klinik und Poliklinik, München, , Germany
Rabin Medical Center - Department of Neurosurgery, Petach Tikva, , Israel
Tel Aviv Sourasky Medical Center (TASMC), Tel Aviv, , Israel
Sheba Medical Center - Department of Neurosurgery, Tel Hashomer, , Israel
Academisch Ziekenhuis Groningen Afd. Neurochirurgie, Groningen, , Netherlands
Erasmus University MC, Rotterdam, Rotterdam, , Netherlands
Institute of Neurological Sciences, Glasgow, , United Kingdom
The Walton Centre for Neurology & Neurosurgery, Liverpool, , United Kingdom
Contact Details
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