The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by:
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00076986
First received: February 6, 2004
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: IL13-PE38QQR
Procedure: surgery and catheter placement (2 procedures)
Drug: prolifespan 20 with carmustine implant (GLIADEL® Wafer)
Procedure: surgery and wafer placement (1 procedure)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by INSYS Therapeutics Inc:

Estimated Enrollment: 300
Study Start Date: February 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Karnofsky Performance Score ≥ 70,
    2. 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.
  • Patients or legal representative must understand the investigational nature of this study and sign a written informed consent form, approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC), prior to performance of any study-specific procedure

Exclusion Criteria:

  • 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:

    1) 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076986

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham - Division of Neurosurgery
Birmingham, Alabama, United States, 35294-3410
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
Los Angeles County/USC
Los Angeles, California, United States, 90033
University of California - Los Angeles Neuro-Oncology Program
Los Angeles, California, United States, 90095-1769
Cedars-Sinai Medical Center - Neurological Institute
Los Angeles, California, United States, 90048
University of California San Francisco - Dept. of Neurological Surgery
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80010
United States, Connecticut
Yale University School of Medicine - Department of Neurosurgery
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Hospital Neuroscience Institute
Orlando, Florida, United States, 32804
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery
Chicago, Illinois, United States, 60611
CINN at Rush Unversity Medical School
Chicago, Illinois, United States, 60612
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201-1782
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, New York
Memorial Sloan Kettering Cancer Center Department of Neurology
New York, New York, United States, 10021
Weill Cornell Medical College - Department of Neurological Surgery
New York, New York, United States, 10021
Columbia University Medical Center - Neurological Institute
New York, New York, United States, 10032
United States, North Carolina
Carolina Neurosurgery & Spine Assoc.
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences - Department of Neurosurgery
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation Department of Neurological Surgery
Cleveland, Ohio, United States, 44195
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Insitute
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health Systems - Department of Neurological Surgery
Charlottesville, Virginia, United States, 22908
United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, West Virginia
West Virginia University Department of Neurosurgery
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Hospital and Clinic
Madison, Wisconsin, United States, 53792
Canada, Alberta
Calgary Health Region
Calgary, Alberta, Canada, T2N 2T9
Walter MacKenzie Health Sciences Center
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
Cancer Care Manitoba
Winnepeg, Manitoba, Canada
Canada, Ontario
London Regional Cancer Center
London, Ontario, Canada, N6A 4L6
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Toronto Western Hospital Division of Neurosurgery
Toronto, Canada
Germany
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, D-24106
Ludwig-Maximilians-Universität München - Klinikum Großhadern - Neurochirurgische Klinik und Poliklinik
München, Germany, D-81377
Israel
Rabin Medical Center - Department of Neurosurgery
Petach Tikva, Israel, 49103
Tel Aviv Sourasky Medical Center (TASMC)
Tel Aviv, Israel, 64246
Sheba Medical Center - Department of Neurosurgery
Tel Hashomer, Israel, 52621
Netherlands
Academisch Ziekenhuis Groningen Afd. Neurochirurgie
Groningen, Netherlands
Erasmus University MC, Rotterdam
Rotterdam, Netherlands
United Kingdom
Institute of Neurological Sciences
Glasgow, United Kingdom, G51 4TF
The Walton Centre for Neurology & Neurosurgery
Liverpool, United Kingdom
Sponsors and Collaborators
INSYS Therapeutics Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00076986     History of Changes
Obsolete Identifiers: NCT00090948
Other Study ID Numbers: IL13PEI-301-R03, PRECISE Trial
Study First Received: February 6, 2004
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by INSYS Therapeutics Inc:
brain tumor
recurrent malignant glioma
brain neoplasm
central nervous system
surgery
resection
GLIADEL
infusion
glioblastoma multiforme
convection-enhanced delivery
first recurrence
recurrent GBM
GBM
supratentorial GBM

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014