Winter 2005 Issue

Innovative Drug & Delivery Method May Revolutionize Treatment Of Brain Tumors

The 12-13 protein targets cancer cells while ignoring healthy ones. Click here to view an animation .
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Carolina Neurosurgery & Spine Associates is participating in a groundbreaking brain tumor study which incorporates both an innovative drug and delivery method. The Phase III Randomized Evaluation of Convection-Enhanced Delivery of IL13-PE38QQR with Survival Endpoint (PRECISE) Trial is one of the largest and most comprehensive clinical trials conducted to date for recurrent glioblastoma multiforme (GBM). It is also the first time an immunotherapy for brain tumors has reached a late phase trial. Carolina Neurosurgery & Spine Associates is among the leading enrollers of patients for the study in the country.

“We are extremely pleased to be a part of this pivotal study,” said Anthony Asher, M.D., FACS, a neurosurgeon with Carolina Neurosurgery & Spine Associates and primary site investigator. “The IL-13 protein targets tumor cells and ignores healthy ones. Additionally, we are bypassing the blood-brain barrier by using convection-enhanced delivery. This unique combination of a novel drug and delivery method has the potential to revolutionize brain tumor therapy.”

The purpose of PRECISE is to study the overall survival durations, safety, and quality of life of patients during treatment with IL13-PE38QQR compared to those treated with GLIADEL® Wafers. Patients will be randomized in a ratio of 2:1 to receive either IL13-PE38QQR, via convection-enhanced delivery, or GLIADEL® Wafers. International enrollment in PRECISE is expected to be completed in late 2005. More information on the PRECISE trial can be found at www.precisetrial.com.


Glioblastoma Multiforme (GBM)
GBM is a highly malignant, infiltrating, primary brain tumor that spreads into surrounding normal brain tissue. This makes GBM tumors very difficult to remove completely with surgery. They can invade the membranes covering the brain, or spread via the spinal fluid through the ventricles of the brain. Malignant gliomas are also known to regrow in a location close to the cavity left by the removal of the tumor. Once the tumor is surgically resected, there are very limited treatment options available to prevent rapid recurrence or progression.

A Seek And Destroy Mission
The purpose of IL13-PE38QQR is to eliminate cancer cells without disturbing healthy cells. This recombinant protein consists of a single molecule composed of two parts: a tumor-targeting molecule (IL13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE). IL13 receptors are found on malignant glioma cells, but not on healthy brain cells. The IL13 portion binds to receptors on the tumor like a key fits in a lock. This causes cancer cells to latch onto and absorb the IL13 and the attached PE. As a result, the cancer cells die. Healthy brain cells are expected to be unharmed because they do not have the IL13 receptors, and therefore do not absorb the PE.

Special Delivery
The barrier between the blood and tissues of the brain prevents the entry of many drugs.
Convection-enhanced delivery utilizes catheters to bypass the blood-brain barrier.Click here to view an animation
Windows Media Player is required and a high speed connection is reccommended.
To overcome the blood-brain barrier, IL13-PE38QQR is administered by a neurosurgeon directly to brain tumors through two to four catheters, placed around the tumor in the brain. The anticancer agent is then delivered continuously by infusion through the catheters for a specified period of time. This method, known as convection enhanced delivery (CED), allows larger areas of the brain to be treated, and also makes it possible to utilize drugs that could not be delivered to the brain in the past.

A Center For Research
The PRECISE trial is just the latest example of Carolina Neurosurgery & Spine Associates’ constant, focused commitment to exploring innovative new brain tumor protocols. The practice has participated in numerous clinical trials for the treatment of brain tumors, including two previous early phase convection delivery trials. The group has also activated a companion study to the Precise trial, the IL13PEI-106 study, in which patients with newly diagnosed malignant primary brain tumors will be eligible for IL-13 toxin administration.

For more information about either of the open IL-13 studies, individuals are encouraged to contact Peggy Boltes, Clinical Trial Coordinator, at 704-376-1605
.


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