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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
Not Enrolling
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

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

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

- 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

- 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:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

March 2007

Related Keywords:

  • Glioblastoma Multiforme
  • brain tumor
  • recurrent malignant glioma
  • brain neoplasm
  • central nervous system
  • surgery
  • resection
  • infusion
  • glioblastoma multiforme
  • convection-enhanced delivery
  • first recurrence
  • recurrent GBM
  • GBM
  • supratentorial GBM
  • Glioblastoma



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