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Intratumoral and intracerebral microinfusion of IL13-PE38QQR cytotoxin: phase I/II study of pre-and post-resection infusions in recurrent resectable malignant glioma. Chemotherapy directed at both the tumor site following biopsy and to brain tissue adjacent to operative site following resection.

Posted on: 05/26/2002

Intratumoral and intracerebral microinfusion of IL13-PE38QQR cytotoxin: phase I/II study of pre-and post-resection infusions in recurrent resectable malignant glioma

Michael D Prados, Frederick F Lang, Lewis C Stauss, Christina K Fleming, Kenneth Aldape, Sandeep Kunwar, W K Alfred Yung, Susan M Chang, Syed R Husain, Philip H Gutin, Jeffrey J Raizer, Joseph M Piepmeier, Mitchel Berger, Michael McDermott, Raj K Puri, Univ of California San Francisco, San Francisco, CA; M.D. Anderson Cancer Center, Houston, TX; NeoPharm Inc, Lake Forest, IL; Center for Biologics, NCI, Bethesda, MD; Memorial Sloan-Kettering, New York, NY; Yale University School of Medicine, New Haven, CT.

Intratumoral (ITM) and Intracerebral microinfusion (ICM) are new approaches to treatment of malignant glioma. IL13-PE38QQR is a novel recombinant cytotoxin consisting of human IL-13 and truncated Pseudomonas exotoxin A lacking the binding domain. Malignant glioma cells express IL-13 receptors at high density, which permit binding of IL13-PE38QQR, cytotoxin internalization and cell death. As tumoricidal concentrations of IL13-PE38QQR may be far below a maximum-tolerated dose (MTD) defined by neurotoxicity, pre-resection ITM may permit identification of a histologically-effective concentration (HEC). After biopsy and catheter placement on Day 1, IL13-PE38QQR is given by ITM over 48 hrs at 400 µL/hr on Day 2-4. Tumor is resected on Day 8, with the goal of en-bloc removal, and tissue evaluated for necrosis adjacent to the catheter. Following resection, 2 or 3 catheters are placed into brain adjacent to operative site; on Days 10-14, IL13-PE38QQR is given by ICM at 750 µL/hr for 96 hrs. Escalation of ITM and ICM concentrations, starting at 0.25 µg/mL, will be performed separately. After an HEC or MTD is identified, ITM will be omitted. Escalation of IL13-PE38QQR concentration will then begin in ICM, and continue up to the identified HEC or MTD. As of 1Dec01, eight patients in the first two dose levels had completed both infusions. Pre-operative infusions were well tolerated in seven patients; in one, progressive tumor-related hemiparesis interrupted ITM. In two patients, transient changes in affect and cognition were noted during infusion. To date, tumor specimen from two patients after ITM at 0.5 µg/mL IL13-PE38QQR revealed regional necrosis in an ovoid zone extending 1 - 2 cm from catheter tip, consistent with drug effect. Using ICM of 72 mL over 4 days (0.25 µg/mL), all patients tolerated infusion well and experienced no subsequent neurotoxicity. To date, four patients have tumor progression (at median 9 weeks); all eight patients remain alive at up to 26+ weeks. Additional patients are being accrued

Source: ASCO Annual Meeting
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