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

NCT ID: NCT00076986

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-03-31

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

prolifespan 20 with carmustine implant (GLIADEL® Wafer)

Intervention Type: DRUG

surgery and wafer placement (1 procedure)

Intervention Type: PROCEDURE

IL13-PE38QQR

Intervention Type: DRUG

surgery and catheter placement (2 procedures)

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INSYS Therapeutics Inc

INDUSTRY

Sponsor Role: lead

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

Petah Tikva, , Israel

Tel Aviv Sourasky Medical Center (TASMC)

Tel Aviv, , Israel

Sheba Medical Center - Department of Neurosurgery

Tel Litwinsky, , 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

Countries

United States; Canada; Germany; Israel; Netherlands; United Kingdom

Related Links

http://www.neophrm.com/index.php?section=1

Click here for more information regarding The PRECISE Trial.

Other Identifiers

PRECISE Trial

Identifier Type: -

Identifier Source: secondary_id

IL13PEI-301-R03

Identifier Type: -

Identifier Source: org_study_id

NCT00090948

Identifier Type: -

Identifier Source: nct_alias