cropped color_logo_with_background.png

Clinical Trial Finder

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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00076986
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 INSYS Therapeutics Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Canada, Germany, Israel, Netherlands, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

University of Alabama at Birmingham - Division of Neurosurgery

Birmingham, Alabama, 35294-3410

City of Hope National Medical Center, Duarte, California

Status

Address

City of Hope National Medical Center

Duarte, California, 91010-3000

Los Angeles County/USC, Los Angeles, California

Status

Address

Los Angeles County/USC

Los Angeles, California, 90033

Los Angeles, California

Status

Address

Cedars-Sinai Medical Center - Neurological Institute

Los Angeles, California, 90048

Los Angeles, California

Status

Address

University of California - Los Angeles Neuro-Oncology Program

Los Angeles, California, 90095-1769

San Francisco, California

Status

Address

University of California San Francisco - Dept. of Neurological Surgery

San Francisco, California, 94143

Aurora, Colorado

Status

Address

University of Colorado Hospital - Anschutz Cancer Pavillion

Aurora, Colorado, 80010

New Haven, Connecticut

Status

Address

Yale University School of Medicine - Department of Neurosurgery

New Haven, Connecticut, 06520

Florida Hospital Neuroscience Institute, Orlando, Florida

Status

Address

Florida Hospital Neuroscience Institute

Orlando, Florida, 32804

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Emory University, Atlanta, Georgia

Status

Address

Emory University

Atlanta, Georgia, 30322

Chicago, Illinois

Status

Address

Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery

Chicago, Illinois, 60611

CINN at Rush Unversity Medical School, Chicago, Illinois

Status

Address

CINN at Rush Unversity Medical School

Chicago, Illinois, 60612

University of Chicago Medical Center, Chicago, Illinois

Status

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

Evanston Northwestern Healthcare, Evanston, Illinois

Status

Address

Evanston Northwestern Healthcare

Evanston, Illinois, 60201-1782

The Johns Hopkins University, Baltimore, Maryland

Status

Address

The Johns Hopkins University

Baltimore, Maryland, 21287

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Henry Ford Health Systems, Detroit, Michigan

Status

Address

Henry Ford Health Systems

Detroit, Michigan, 48202

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

St. Louis University, St. Louis, Missouri

Status

Address

St. Louis University

St. Louis, Missouri, 63104

New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center Department of Neurology

New York, New York, 10021

New York, New York

Status

Address

Weill Cornell Medical College - Department of Neurological Surgery

New York, New York, 10021

New York, New York

Status

Address

Columbia University Medical Center - Neurological Institute

New York, New York, 10032

Carolina Neurosurgery & Spine Assoc., Charlotte, North Carolina

Status

Address

Carolina Neurosurgery & Spine Assoc.

Charlotte, North Carolina, 28204

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

Winston-Salem, North Carolina

Status

Address

Wake Forest University Health Sciences - Department of Neurosurgery

Winston-Salem, North Carolina, 27157

Cleveland, Ohio

Status

Address

Cleveland Clinic Foundation Department of Neurological Surgery

Cleveland, Ohio, 44195

The Ohio State University Medical Center, Columbus, Ohio

Status

Address

The Ohio State University Medical Center

Columbus, Ohio, 43210

Oregon Health & Science University, Portland, Oregon

Status

Address

Oregon Health & Science University

Portland, Oregon, 97239

Philadelphia, Pennsylvania

Status

Address

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Baptist Memorial Hospital, Memphis, Tennessee

Status

Address

Baptist Memorial Hospital

Memphis, Tennessee, 38120

UT Southwestern Medical Center, Dallas, Texas

Status

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Baylor College of Medicine, Houston, Texas

Status

Address

Baylor College of Medicine

Houston, Texas, 77030

Houston, Texas

Status

Address

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

Huntsman Cancer Insitute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Insitute

Salt Lake City, Utah, 84132

Charlottesville, Virginia

Status

Address

University of Virginia Health Systems - Department of Neurological Surgery

Charlottesville, Virginia, 22908

Seattle, Washington

Status

Address

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, 98101

Morgantown, West Virginia

Status

Address

West Virginia University Department of Neurosurgery

Morgantown, West Virginia, 26506

Madison, Wisconsin

Status

Address

University of Wisconsin Hospital and Clinic

Madison, Wisconsin, 53792

International Sites

Calgary Health Region, Calgary, Alberta, Canada

Status

Address

Calgary Health Region

Calgary, Alberta, T2N 2T9

Walter MacKenzie Health Sciences Center, Edmonton, Alberta, Canada

Status

Address

Walter MacKenzie Health Sciences Center

Edmonton, Alberta, T6G 2B7

Cancer Care Manitoba, Winnepeg, Manitoba, Canada

Status

Address

Cancer Care Manitoba

Winnepeg, Manitoba,

London Regional Cancer Center, London, Ontario, Canada

Status

Address

London Regional Cancer Center

London, Ontario, N6A 4L6

Toronto, Ontario, Canada

Status

Address

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5

Montreal, Quebec, Canada

Status

Address

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4

Royal University Hospital, Saskatoon, Saskatchewan, Canada

Status

Address

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8

Toronto, Canada

Status

Address

Toronto Western Hospital Division of Neurosurgery

Toronto, ,

Dresden, Germany

Status

Address

Techniche Universität Dresden Klinik und Poliklinik für Neurochirurgie

Dresden, ,

Hamburg, Germany

Status

Address

Universitätsklinikum Hamburg-Eppendorf - Klinik für Neurochirurgie

Hamburg, ,

Klinikum der Universität Heidelberg, Heidelberg, Germany

Status

Address

Klinikum der Universität Heidelberg

Heidelberg, ,

Kiel, Germany

Status

Address

Universitätsklinikum Schleswig-Holstein - Klinik für Neurochirurgie

Kiel, , D-24106

München, Germany

Status

Address

Ludwig-Maximilians-Universität München - Klinikum Großhadern - Neurochirurgische Klinik und Poliklinik

München, , D-81377

Petach Tikva, Israel

Status

Address

Rabin Medical Center - Department of Neurosurgery

Petach Tikva, , 49103

Tel Aviv Sourasky Medical Center (TASMC), Tel Aviv, Israel

Status

Address

Tel Aviv Sourasky Medical Center (TASMC)

Tel Aviv, , 64246

Tel Hashomer, Israel

Status

Address

Sheba Medical Center - Department of Neurosurgery

Tel Hashomer, , 52621

Groningen, Netherlands

Status

Address

Academisch Ziekenhuis Groningen Afd. Neurochirurgie

Groningen, ,

Erasmus University MC, Rotterdam, Rotterdam, Netherlands

Status

Address

Erasmus University MC, Rotterdam

Rotterdam, ,

Institute of Neurological Sciences, Glasgow, United Kingdom

Status

Address

Institute of Neurological Sciences

Glasgow, , G51 4TF

Liverpool, United Kingdom

Status

Address

The Walton Centre for Neurology & Neurosurgery

Liverpool, ,

Powered By