Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
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.