Publications [#140381] of John H Sampson

Papers Published

1. S Kunwar, MD Prados, SM Chang, MS Berger, FF Lang, JM Piepmeier, JH Sampson, Z Ram, PH Gutin, RD Gibbons, KD Aldape, DJ Croteau, JW Sherman, RK Puri, Cintredekin Besudotox Intraparenchymal Study Group, Direct intracerebral delivery of cintredekin besudotox (IL13-PE38QQR) in recurrent malignant glioma: a report by the Cintredekin Besudotox Intraparenchymal Study Group., Journal of clinical oncology : official journal of the American Society of Clinical Oncology, United States, vol. 25 no. 7 (March, 2007), pp. 837-44, ISSN 1527-7755
   (last updated on 2007/12/20)

   Abstract:
   PURPOSE: Glioblastoma multiforme (GBM) is a devastating brain tumor with a median survival of 6 months after recurrence. Cintredekin besudotox (CB) is a recombinant protein consisting of interleukin-13 (IL-13) and a truncated form of Pseudomonas exotoxin (PE38QQR). Convection-enhanced delivery (CED) is a locoregional-administration method leading to high-tissue concentrations with large volume of distributions. We assessed the use of intracerebral CED to deliver CB in patients with recurrent malignant glioma (MG). PATIENTS AND METHODS: Three phase I clinical studies evaluated intracerebral CED of CB along with tumor resection. The main objectives were to assess the tolerability of various concentrations and infusion durations; tissue distribution; and methods for optimizing delivery. All patients underwent tumor resection followed by a single intraparenchymal infusion (in addition to the intraparenchymal one following resection), with a portion of patients who had a preresection intratumoral infusion. RESULTS: A total of 51 patients with MG were treated including 46 patients with GBM. The maximum tolerated intraparenchymal concentration was 0.5 microg/mL and tumor necrosis was observed at this concentration. Infusion durations of up to 6 days were well tolerated. Postoperative catheter placement appears to be important for optimal drug distribution. CB- and procedure-related adverse events were primarily limited to the CNS. Overall median survival for GBM patients is 42.7 weeks and 55.6 weeks for patients with optimally positioned catheters with patient follow-up extending beyond 5 years. CONCLUSION: CB appears to have a favorable risk-benefit profile. CED is a complex delivery method requiring catheter placement via a second procedure to achieve accurate catheter positioning, better drug distribution, and better outcome.

   Keywords:
   Adult • Aged • Catheterization • Convection • Drug Delivery Systems • Exotoxins • Female • Glioma • Humans • Immunotoxins • Interleukin-13 • Male • Middle Aged • Neoplasm Recurrence, Local • Supratentorial Neoplasms • Tissue Distribution • administration & dosage* • adverse effects • drug therapy* • methods* • mortality • pharmacokinetics