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NCT00041587 · ClinicalTrials.gov registry record · Phase 1
Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00041587 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 80 participants.
The verdict
NCT00041587, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL13-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the IL13 receptors was shown to be highly specific for human glioma cells. Prior to treatment, patients will have physical and neurologic exams, MRI to measure the extent of tumor, tumor biopsy, and screening laboratory tests. On Day 1, one or two catheters will be inserted directly into the tumor, after which a CT scan will be used to confirm placement. Each patient will receive one IL13-PE38QQR infusion, and the tumor will be surgically removed on approximately Day 15. In the first group of patients, IL13-PE38QQR will be infused directly into the tumor for 4 days. Depending on effectiveness or side effects of the study drug, the duration will be increased stepwise to a maximum of 7 days in subsequent groups of patients. Once duration of infusion has been determined, the dose of IL13-PE38QQR will be increased stepwise (in separate groups of patients), depending on effectiveness or side effects of the study drug. The activity of the drug against the tumor cells will be judged by examining the removed tumor tissue. Patients will have neurologic exams and MRI scans immediately after the resection and every eight weeks until disease progression is observed.
Interventions
- PROCEDURE surgery
- DRUG IL13-PE38QQR
- PROCEDURE targeted fusion protein therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2002-07 |
| Est. Completion | 2007-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00041587
The ClinicalTrials.gov registry entry for NCT00041587 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which surgery is the first listed.
NCT00041587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00041587 about?
NCT00041587 is a clinical study titled "Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma". IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL13-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic benefit. In reciprocal com...
What is the current status of trial NCT00041587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2002-07. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00041587?
The interventions under investigation include: surgery (PROCEDURE), IL13-PE38QQR (DRUG), targeted fusion protein therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00041587?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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