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NCT00880061 · ClinicalTrials.gov registry record · Phase 1
An Open Label Dose Escalation Safety Study of Convection-Enhanced Delivery of IL13-PE38QQR in Patients With Progressive Pediatric Diffuse Infiltrating Brainstem Glioma and Supratentorial High-grade Glioma
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00880061 is a Phase 1 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 7 participants.
The verdict
NCT00880061, a Phase 1 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: * 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 large molecules through the membranes protecting the brain to reach brain tumors. This technique can treat a tumor more directly than with traditional methods. Objectives: * To test the safety and feasibility of giving IL13-PE38QQR directly into regions of the brain in pediatric patients with DIPG or HGG, using CED. * To determine the most appropriate dose of IL13-PE38QQR to treat DIPG or HGG. * To determine the effects of this experimental therapy on the tumor. * To evaluate the physical changes in the tumor before and after the therapy. Eligibility: * Patients who are less than 18 years of age and have been diagnosed with either DIPG or with supratentorial HGG that has not responded well to standard treatments. Design: * Patients will be admitted to the hospital and will receive a magnetic resonance imaging (MRI) scan to show the exact location of the tumor. A small plastic tube will be inserted surgically into the tumor area, and IL13-PE38QQR and a 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
Interventions
- DRUG IL13-PE38QQR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-04-07 |
| Est. Completion | 2015-06-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00880061
The ClinicalTrials.gov registry entry for NCT00880061 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IL13-PE38QQR is the first listed.
NCT00880061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00880061 about?
NCT00880061 is a clinical study titled "An Open Label Dose Escalation Safety Study of Convection-Enhanced Delivery of IL13-PE38QQR in Patients With Progressive Pediatric Diffuse Infiltrating Brainstem Glioma and Supratentorial High-grade Glioma". Background: * 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 ...
What is the current status of trial NCT00880061?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2009-04-07. Estimated completion is 2015-06-05.
What interventions are being tested in trial NCT00880061?
The interventions under investigation include: IL13-PE38QQR (DRUG).
Who is sponsoring clinical trial NCT00880061?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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