Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma
Completed · Phase 1/Phase 2
Conditions studied: Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Mixed Oligoastrocytoma
In brief
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.
Key facts
- Study ID
- NCT00041587
- Run by
- INSYS Therapeutics Inc
- People needed
- 80
- Starts
- 2002-07-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2011-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Colorado Health Sciences Center — Denver, Colorado, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- University Hospital Eppendorf — Hamburg, Germany
- University Hospital Kiel, Department of Neurosurgery — Kiel, Germany
- Sourasky Medical Center — Tel Aviv, Israel
- Chaim Sheba Medical Center — Tel Litwinsky, Israel
Full record on ClinicalTrials.gov
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