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Progress Report of a Phase I Study of the Intracerebral Microinfusion of a Recombinant Chimeric Protein Composed of Transforming Growth Factor (TGF)-á and a Mutated form of the Pseudomonas Exotoxin Termed PE-38 (TP-38) for the Treatment of Malignant Brain Tumors


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Website: http://www.brainlife.org/treatment/ongoing/toxin/sampson_2003oct.htm

Posted on: 11/10/2003

Journal of Neuro-Oncology, October 2003, Volume 65, Number, 1, Pages 27 – 35 (Abstract)

Progress Report of a Phase I Study of the Intracerebral Microinfusion of a Recombinant Chimeric Protein Composed of Transforming Growth Factor (TGF)-á and a Mutated form of the Pseudomonas Exotoxin Termed PE-38 (TP-38) for the Treatment of Malignant Brain Tumors

J.H. Sampson ; G. Akabani ; G.E. Archer ; D.D. Bigner ; M.S. Berger ; A.H. Friedman ; H.S. Friedman ; J.E. Herndon II ; S. Kunwar ; S. Marcus ; R.E. McLendon ; A. Paolino ; K. Penne ; J. Provenzale ; J. Quinn ; D.A. Reardon ; J. Rich ; T. Stenzel ; S. Tourt-Uhlig ; C. Wikstrand ; T. Wong ; R. Williams ; F. Yuan ; M.R. Zalutsky ; I. Pastan

TP-38 is a recombinant chimeric targeted toxin composed of the EGFR binding ligand TGF-á and a genetically engineered form of the Pseudomonas exotoxin, PE-38. After in vitro and in vivo animal studies that showed specific activity and defined the maximum tolerated dose (MTD), we investigated this agent in a Phase I trial. The primary objective of this study was to define the MTD and dose limiting toxicity of TP-38 delivered by convection-enhanced delivery in patients with recurrent malignant brain tumors. Twenty patients were enrolled in the study and doses were escalated from 25 ng/mL to 100 with a 40 mL infusion volume delivered by two catheters. One patient developed Grade IV fatigue at the 100 ng/mL dose, but the MTD has not been established. The overall median survival after TP-38 for all patients was 23 weeks whereas for those without radiographic evidence of residual disease at the time of therapy, the median survival was 31.9 weeks. Overall, 3 of 15 patients, with residual disease at the time of therapy, have demonstrated radiographic responses and one patient with a complete response and has survived greater than 83 weeks.

Keywords: brain neoplasms; convection-enhanced delivery; immunotoxin

© 2003 Kluwer Academic Publishers



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