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56. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e. V. (DGNC)
3èmes journées françaises de Neurochirurgie (SFNC)

Deutsche Gesellschaft für Neurochirurgie e. V.
Société Française de Neurochirurgie

07. bis 11.05.2005, Strasbourg

*IM-20 - preliminary results of a phase II study of TP-38 immunotoxin delivered via convection-enhanced delivery to patients with recurrent glioblastoma multiforme: report of the TP-38 study group

Gesammelte Studienresultate einer Phase II Studie bei der Behandlung von Patienten mit Glioblastomrezidiven durch "CED" mit dem Immuntoxin TP-38 : Bericht der TP-38 Studiengruppe

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  • corresponding author F. Weber - Klinik für Neurochirurgie, Klinikum Saarbrücken

Deutsche Gesellschaft für Neurochirurgie. Société Française de Neurochirurgie. 56. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), 3èmes journées françaises de Neurochirurgie (SFNC). Strasbourg, 07.-11.05.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc09.05.-18.04

The electronic version of this article is the complete one and can be found online at:

Published: May 4, 2005

© 2005 Weber.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.




TP-38 is a recombinant chimeric protein composed of the epidermal growth factor receptor (EGFR) binding ligand (TGF-α) and a genetically engineered form of the Pseudomonas exotoxin PE-38. We report preliminary results of a randomized phase II study conducted at multiple European centers. Either of two dose levels of TP-38 (50 ng/ml or 100 ng/ml) was administered to patients with recurrent gliolblastoma in a single treatment consisting of a continuous intratumoural infusion.


This was a non-resection study; patients did not undergo tumour resection immediately prior to treatment. Three catheters were stereotactically placed in investigator-determined locations within the enhancing tumour area. The infusion rate was 0.2 ml/min per catheter. Each catheter delivered 13.4 ml over 67 h. The total volume infused was approximately 40 ml, and the total dose of TP-38 infused was approximately 2μg or 4μg. Patients were followed until death. Tumour response was assessed by MRI every 8 weeks, beginning 4 weeks after treatment. Safety was closely evaluated. Time to progression, progression-free survival, and overall survival were the measured end points.


Thirty-four of the planned 38 patients have been treated thus far. Safety and tolerability have been excellent. The 4-week and 12-week post-infusion MRI scans often showed treatment-related changes that make response assessment difficult. These changes usually resolved by the 20-week post treatment MRI. Preliminary data show that one patient has a complete response 48 weeks after infusion, and another patient showed a partial response over 60 weeks, 24 patients remained stable.


These results in a not highly selected group of patients suffering from recurrent glioblastoma are so promising that we proceed with a second trial where the tumour gets first resected and the area adjacent to the tumour will then be treated by CED of TP38.