D. Anderson Cancer Center, Houston, TX, USA, 5University of Virginia, Charlottesville, VA, USA, 6Carolina Neurosurgery and Spine Associates, Charlotte, NC, USA, 7NeoPharm, Inc. Lake Forest, IL, USA, 8CBER, U. S. FDA, Bethesda, MD, USA Cintredekin besudotox, a recombinant protein consisting of IL13 and truncated Pseudomonas VEGF receptor antagonist exotoxin, binds selectively to IL13RA2 receptors overexpressed by malignant glioma. This examine assessed the security of CB administered by convection enhanced delivery fol lowed by typical external beam radiotherapy with or without temozolomide in patients with newly diagnosed MG. Soon after a gross complete resection from the tumor, two to four intraparenchymal catheters have been stero tactically positioned and CB was infused for 96 hours. Ten to 14 days later on, EBRT was offered with or with no TMZ. Safety was assessed over an 11 week observation time period after catheter placement.
Twenty two patients had been enrolled. No individuals seasoned dose limiting toxicities inside the to begin with 2 cohorts. One patient our site expe rienced a DLT from the third cohort. Four individuals from the last cohort completed remedy, and two patients are at the moment receiving treatment without any DLTs reported. 4 sufferers had been not thought to be evaluable for dose choice and have been replaced. CB associated adverse occasions that occurred in greater than one patient had been cognitive disorder, asthenia, and sensory disturbance. No Grade III IV hematologic toxicities have been observed. The overall survival extends as much as 86 weeks to date. The convection enhanced delivery of CB followed by EBRT six TMZ seems to get very well tolerated in adults with newly diagnosed MG. TA 64. BEVACIZUMAB AND IRINOTECAN Is definitely an Productive Treatment method FOR MALIGNANT GLIOMAS James Vredenburgh, Annick Desjardins, James E.
Herndon II, David Reardon, Jennifer Quinn, Sith Sathornsumetee, Sridharan Gururangan, Allan Friedman, Darell Bigner, and Henry Friedman, Duke University Medical Center, Durham, NC, USA The prognosis for recurrent malignant gliomas is poor, using a median survival time significantly less than ten months. Malignant gliomas have large concen trations of VEGF receptors, plus the higher the VEGF receptor concentra tion, the worse the prognosis. Bevacizumab is really a humanized IgG1 monoclo nal antibody to VEGF, which is synergistic with chemotherapy for many malignancies. Irinotecan can be a topoisomerase one inhibitor and has modest action towards recurrent malignant gliomas. We report an FDA authorized phase II trial of bevacizumab and irinotecan for your remedy of recurrent malignant gliomas. Sixty eight sufferers had been enrolled, 32 with grade IV tumors and 36 with grade III tumors. All individuals had progressive disorder and underwent preceding radiation treatment and chemotherapy.