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