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PREVIOUS CLINICAL TRIALS
A total of six clinical trials have been completed in glioblastoma multiforme using Neuradiab or closely related therapies. (Published details from these trials are described in the Publication section of this website. Neuradiab is referred to in these publications by its laboratory name, I-131 labeled 81C6). Most recently, a Phase II trial was completed in which the delivered dose of the drug was tailored specifically for each patient.
The amount of radioactivity actually absorbed into the tumor cells from the instilled antibody is highly dependent upon the size and shape of the cavity and other patient-specific characteristics. In order to maximize the clinical benefit of Neuradiab, dosimetry can be performed upon the patient to define a patient-specific preferred dose of the therapy. Such a technique was therefore employed in this clinical trial. The protocol for this Phase II trial of patients with newly diagnosed GBM was designed such that a low dose of Neuradiab was first administered into the surgically created resection cavity to assess residence time in the cavity. Based on this dosimetry information, the amount of Neuradiab administered was adjusted for each patient to deliver a patient-specific optimal absorbed dose. These patients were also treated with external beam radiotherapy and chemotherapy. Using this patient specific dosing regimen, median survival was significantly increased compared to currently approved therapies.
CURRENT CLINICAL TRIALS
A large, multi-center, randomized trial is currently underway, the goal of which is to compare the effects of the Neuradiab therapy regimen together with standard-of-care therapy to the standard-of-care therapy alone, in newly diagnosed glioblastoma multiforme patients.
It is called the GLASS-ART (GBM Locoregional Agent Survival Study of Anti-tenascin Radiolabeled antibody Therapy) Trial. To get more information about this trial:
phone: (888) 267-0707 Ext. 1
email: glassart@bradmerpharma.com
website: GlassArtTrial.com
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