The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
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
2 other identifiers
interventional
300
6 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2004
Typical duration for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 6, 2004
CompletedFirst Posted
Study publicly available on registry
February 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJune 6, 2011
June 1, 2011
3.1 years
February 6, 2004
June 2, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be ≥ 18 years old.
- Patients must have clinical and/or radiographic evidence of FIRST recurrence or progression of supratentorial GBM afer a previous resection or biopsy and external beam radiation therapy.
- Patients must have histopathologic documentation of GBM at initial diagnosis.
- Patients must have had previous cytoreductive surgery or biopsy for GBM.
- Patients must have received external beam radiotherapy with ≥ 45 Gy tumor dose, completed ≥ 4 weeks prior to study entry.
- Gross total resection (i.e., ≥ 95% resection of the solid, contrast-enhancing tumor component) must be planned.
- Tumor must have a solid contrast-enhancing component ≥ 1.0 cm in diameter. Baseline measurements must be obtained ≤ 2 weeks prior to study entry.
- Patients must be in adequate condition, as indicated by:
- Karnofsky Performance Score ≥ 70,
- Adequate hematologic status: i. Absolute neutrophil count (ANC) ≥ 1,500/mm3; ii. Hemoglobin ≥ 10 gm/dL; iii. Platelets ≥ 100,000/mm3; iv. PT and aPTT ≤ 1.5 x institutional upper limit
- Patients must not be receiving concurrent anti-tumor therapy and must have recovered from toxicity of prior therapy. Minimum intervals required:
- ≥ 6 weeks after receiving nitrosourea cytotoxic drug
- ≥ 4 weeks after receiving any non-nitrosourea cytotoxic drug or any systemic investigational agent
- ≥ 2 weeks after receiving any non-cytotoxic anti-tumor drug (including celecoxib or other drugs, if they are being used as anti-tumor therapies)
- Patients must be willing to practice an effective method of birth control during the study. Female patients must not be pregnant or breast-feeding.
- +1 more criteria
You may not qualify if:
- Patients with contrast-enhancing tumor component crossing the midline, multi-focal tumor not amenable to gross total resection, or tumor dissemination (subependymal or leptomeningeal).
- Expected communication between ventricle and resection cavity that cannot be repaired in order to safely use GLIADEL® Wafer.
- Patients with clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment.
- Patients who have received any type of stereotactic radiosurgery or brachytherapy, with the exception of the stereotactic radiosurgery boost part of the initial fractionated external beam radiation therapy.
- Patients who have received:
- \) prior treatment with IL13-PE38QQR, or, 2) GLIADEL® Wafer, or, 3) any intracerebral investigational agent
- Patients who have demonstrated a previous hypersensitivity to BCNU or any other component of the GLIADEL® Wafer.
- Patients unwilling or unable to follow protocol requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
University of Alabama at Birmingham - Division of Neurosurgery
Birmingham, Alabama, 35294-3410, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Los Angeles County/USC
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center - Neurological Institute
Los Angeles, California, 90048, United States
University of California - Los Angeles Neuro-Oncology Program
Los Angeles, California, 90095-1769, United States
University of California San Francisco - Dept. of Neurological Surgery
San Francisco, California, 94143, United States
University of Colorado Hospital - Anschutz Cancer Pavillion
Aurora, Colorado, 80010, United States
Yale University School of Medicine - Department of Neurosurgery
New Haven, Connecticut, 06520, United States
Florida Hospital Neuroscience Institute
Orlando, Florida, 32804, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery
Chicago, Illinois, 60611, United States
CINN at Rush Unversity Medical School
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201-1782, United States
The Johns Hopkins University
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Henry Ford Health Systems
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Louis University
St Louis, Missouri, 63104, United States
Memorial Sloan Kettering Cancer Center Department of Neurology
New York, New York, 10021, United States
Weill Cornell Medical College - Department of Neurological Surgery
New York, New York, 10021, United States
Columbia University Medical Center - Neurological Institute
New York, New York, 10032, United States
Carolina Neurosurgery & Spine Assoc.
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences - Department of Neurosurgery
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Foundation Department of Neurological Surgery
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Insitute
Salt Lake City, Utah, 84132, United States
University of Virginia Health Systems - Department of Neurological Surgery
Charlottesville, Virginia, 22908, United States
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, 98101, United States
West Virginia University Department of Neurosurgery
Morgantown, West Virginia, 26506, United States
University of Wisconsin Hospital and Clinic
Madison, Wisconsin, 53792, United States
Calgary Health Region
Calgary, Alberta, T2N 2T9, Canada
Walter MacKenzie Health Sciences Center
Edmonton, Alberta, T6G 2B7, Canada
Cancer Care Manitoba
Winnepeg, Manitoba, Canada
London Regional Cancer Center
London, Ontario, N6A 4L6, Canada
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, 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, D-24106, Germany
Ludwig-Maximilians-Universität München - Klinikum Großhadern - Neurochirurgische Klinik und Poliklinik
München, D-81377, Germany
Rabin Medical Center - Department of Neurosurgery
Petah Tikva, 49103, Israel
Tel Aviv Sourasky Medical Center (TASMC)
Tel Aviv, 64246, Israel
Sheba Medical Center - Department of Neurosurgery
Tel Litwinsky, 52621, Israel
Academisch Ziekenhuis Groningen Afd. Neurochirurgie
Groningen, Netherlands
Erasmus University MC, Rotterdam
Rotterdam, Netherlands
Institute of Neurological Sciences
Glasgow, G51 4TF, United Kingdom
The Walton Centre for Neurology & Neurosurgery
Liverpool, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2004
First Posted
February 10, 2004
Study Start
February 1, 2004
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
June 6, 2011
Record last verified: 2011-06