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Brain Tumor

NINDS-09-N-0117, NCT00880061

Investigator(s):
Russell R. Lonser, M.D. Principal Investigator Phone: 301-496-5728 Fax: 301-402-0380 lonserr@ninds.nih.gov	Katherine E. Warren, M.D. Lead Associate Investigator Phone: 301-496-4256 Fax: 301-480-2308 warrenk@mail.nih.gov
Referral Contact(s):
Linda Ellison, R.N. Research Nurse Phone: 301-496-8009 Fax: 301-480-8871 ellisonl@mail.nih.gov	Pediatric Oncology Phone: 301-496-4256 1-877-624-4878 (Toll free)

Diffusely infiltrating pontine glioma (DIPG) or supratentorial high-grade glioma (HGG) are brain tumors that are often difficult to treat; it is very difficult to get chemotherapy agents to tumors in the brain, and researchers are looking for new methods to directly treat these types of cancer
IL-13 is an immune molecule normally occurring in the body; patients with gliomas appear to have significant amounts of the IL-13 receptors in their brain tumors
An experimental drug, IL13-PE38QQR, combines a bacteria toxin with human IL-13 to allow the toxin to enter and destroy the tumor cell; early clinical studies suggest this treatment may prolong survival of patients with these types of brain tumors
A technique called convection-enhanced delivery (CED) uses continuous pressure to push agents across brain tissue; this technique delivers the therapy directly to the tumor
A catheter is inserted into the tumor and an antitumor agent is then infused using the CED

Test the safety and feasibility of giving IL13-PE38QQR directly into regions of the brain in pediatric patients with diffusely infiltrating pontine glioma (DIPG) or high-grade glioma (HGG) using convection-enhanced delivery (CED)
Determine the most appropriate dose of IL13-PE38QQR to treat DIPG or HGG
Determine the effects of this experimental therapy on the tumor
Evaluate the physical changes in the tumor before and after the therapy

Histopathologic diagnosis is not required, but a biopsy may be recommended if the patient has an atypical presentation or atypical findings on magnetic resonance imaging (MRI)

Histopathologic confirmation is required; if necrosis is suspected based on MRI and nuclear medicine scans, biopsy or surgical resection for confirmation of disease progression may be required

Recurrent or progressive disease after prior treatment
Patients undergoing surgical resection of HGG must have measurable/evaluable disease prior to study entry
Adequate organ function
Able to undergo MRI with gadolinium-based contrast administration

Patients will be admitted to the NIH clinical center
Magnetic resonance imaging (MRI) scan with spectroscopy will be performed to show the exact location of the tumor and its metabolism
A small plastic tube will be inserted surgically into the tumor area
IL13-PE38QQR and an MRI contrast agent (gadolinium DTPA) will be infused into the area
MRI scans will monitor the process, and the tube will be removed after surgery
Doses will be adjusted over the course of the study
Patients who respond well to treatment may be eligible to receive a second infusion no sooner than 4 weeks after the first treatment
Clinic visits 4 and 8 weeks after the treatment and then every 8 weeks for up to 1 year will include physical examination with neurological testing, an MRI, and standard blood and urine tests

This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
There is no charge for medical care received at NIH Clinical Center.

PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed:
Updated: 8/1/12