Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent 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). IL3-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. IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly into the malignant brain tumors of patients to determine the dose of drug these patients can tolerate. After that, the selected dose will be studied to give an estimate of the response rate, response duration, time to response, and survival after infusing that dose of IL13-PE38QQR into the recurrent malignant glioma.

Key facts

Study ID: NCT00024570
Run by: INSYS Therapeutics Inc
People needed: 60
Starts: 2000-11-01
Expected to finish: 2007-07-01
Last updated by the study team: 2014-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
The Johns Hopkins University — Baltimore, Maryland, United States
Henry Ford Health Systems — Detroit, Michigan, United States
Wake Forest University — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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