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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076986
• Other study ID #: IL13PEI-301-R03
• Secondary ID: PRECISE Trial
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2004
• Last updated: June 2, 2011
• Start date: February 2004
• Est. completion date: March 2007

Study information

• Verified date: June 2011
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00090948

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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)

Locations

Country	Name	City	State
Canada	Calgary Health Region	Calgary	Alberta
Canada	Walter MacKenzie Health Sciences Center	Edmonton	Alberta
Canada	London Regional Cancer Center	London	Ontario
Canada	Montreal Neurological Institute and Hospital	Montreal	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital Division of Neurosurgery	Toronto
Canada	Cancer Care Manitoba	Winnepeg	Manitoba
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	Ludwig-Maximilians-Universität München - Klinikum Großhadern - Neurochirurgische Klinik und Poliklinik	München
Israel	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
Netherlands	Academisch Ziekenhuis Groningen Afd. Neurochirurgie	Groningen
Netherlands	Erasmus University MC, Rotterdam	Rotterdam
United Kingdom	Institute of Neurological Sciences	Glasgow
United Kingdom	The Walton Centre for Neurology & Neurosurgery	Liverpool
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Hospital - Anschutz Cancer Pavillion	Aurora	Colorado
United States	The Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham - Division of Neurosurgery	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolina Neurosurgery & Spine Assoc.	Charlotte	North Carolina
United States	University of Virginia Health Systems - Department of Neurological Surgery	Charlottesville	Virginia
United States	CINN at Rush Unversity Medical School	Chicago	Illinois
United States	Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological Surgery	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation Department of Neurological Surgery	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health Systems	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Cedars-Sinai Medical Center - Neurological Institute	Los Angeles	California
United States	Los Angeles County/USC	Los Angeles	California
United States	University of California - Los Angeles Neuro-Oncology Program	Los Angeles	California
United States	University of Wisconsin Hospital and Clinic	Madison	Wisconsin
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	West Virginia University Department of Neurosurgery	Morgantown	West Virginia
United States	Yale University School of Medicine - Department of Neurosurgery	New Haven	Connecticut
United States	Columbia University Medical Center - Neurological Institute	New York	New York
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	Florida Hospital Neuroscience Institute	Orlando	Florida
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Huntsman Cancer Insitute	Salt Lake City	Utah
United States	University of California San Francisco - Dept. of Neurological Surgery	San Francisco	California
United States	Benaroya Research Institute at Virginia Mason Medical Center	Seattle	Washington
United States	St. Louis University	St. Louis	Missouri
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Wake Forest University Health Sciences - Department of Neurosurgery	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Israel,  Netherlands,  United Kingdom,