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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

IL13PEI-301-R03

NCT ID:

NCT00076986

Start Date:

February 2004

Completion Date:

March 2007

Related Keywords:

  • Glioblastoma Multiforme
  • 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
  • Glioblastoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Mayo ClinicRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Medical University of South CarolinaCharleston, South Carolina  29425-0721
City of Hope National Medical CenterLos Angeles, California  91010
Baptist Memorial HospitalMemphis, Tennessee  38146
Evanston Northwestern HealthcareEvanston, Illinois  60201
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
Emory UniversityAtlanta, Georgia  30322
The Johns Hopkins UniversityBaltimore, Maryland  21287
Henry Ford Health SystemsDetroit, Michigan  48202
University of Chicago Medical CenterChicago, Illinois  60637
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030
St. Louis UniversitySt. Louis, Missouri  63110
Ut Southwestern Medical CenterDallas, Texas  75390
University of Alabama at Birmingham - Division of NeurosurgeryBirmingham, Alabama  35294-3410
Los Angeles County/USCLos Angeles, California  90033
University of California - Los Angeles Neuro-Oncology ProgramLos Angeles, California  90095-1769
Cedars-Sinai Medical Center - Neurological InstituteLos Angeles, California  90048
University of California San Francisco - Dept. of Neurological SurgerySan Francisco, California  94143
University of Colorado Hospital - Anschutz Cancer PavillionAurora, Colorado  80010
Yale University School of Medicine - Department of NeurosurgeryNew Haven, Connecticut  06520
Florida Hospital Neuroscience InstituteOrlando, Florida  32804
Northwestern Medical Faculty Foundation, Inc. - Dept of Neurological SurgeryChicago, Illinois  60611
CINN at Rush Unversity Medical SchoolChicago, Illinois  60612
Memorial Sloan Kettering Cancer Center Department of NeurologyNew York, New York  10021
Weill Cornell Medical College - Department of Neurological SurgeryNew York, New York  10021
Columbia University Medical Center - Neurological InstituteNew York, New York  10032
Carolina Neurosurgery & Spine Assoc.Charlotte, North Carolina  28204
Wake Forest University Health Sciences - Department of NeurosurgeryWinston-Salem, North Carolina  27157
Cleveland Clinic Foundation Department of Neurological SurgeryCleveland, Ohio  44195
The Ohio State University Medical CenterColumbus, Ohio  43210
The Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Huntsman Cancer InsituteSalt Lake City, Utah  84132
University of Virginia Health Systems - Department of Neurological SurgeryCharlottesville, Virginia  22908
Benaroya Research Institute at Virginia Mason Medical CenterSeattle, Washington  98101
West Virginia University Department of NeurosurgeryMorgantown, West Virginia  26506
University of Wisconsin Hospital and ClinicMadison, Wisconsin  53792