Introduction: Glioblastoma multiforme (GBM) is the most common /clinically aggressive of primary brain tumors. Prolongation of survival for recurrent GBM has not been convincingly demonstrated with any treatment strategy. 131I-chTNT-1/B MAb is a radioiodinated chimeric monoclonal antibody specific for DNA and histone H1 complex exposed in necrotic core of malignant gliomas.
Methods: Phase II, open-label, dose confirmatory study. Patients aged 18 to 75 years with histologically confirmed GBM at first relapse, clinical target volume (CTV) of 5 to 60 cc, and Karnofsky Performance Status =70% were eligible. Drug adminstered by convection enhanced delivery via 2 catheters placed under stereotactic guidance, at a constant rate of 0.18 mL/h for 25 hours at dose of 2.5 mCi/cc of CTV. Additional endpoints included overall survival (OS), progression free survival (PFS), and proportion of patients alive at 6 months
Results: 41 cases were enrolled and received study drug. Mean age was 52 years (24-74). Median CTV was 28.3 cc (1.6-65.8) and median KPS was 80 (70-100). The median administered therapeutic dose was 66.9 mCi (3.5 to 148) with most patients receiving >90% of planned therapy dose. The most common overall adverse events (AEs) (> 10%) were: brain edema (32%), headache (22%), convulsions (20%) and amnesia (12%).Interim median OS currently at 38 weeks and median PFS at 23 weeks
Conclusions: Single interstitial administration of study drug at 2.5 mCi/cc was well-tolerated in this study of patients with recurrent GBM. Follow-up is continuing, current median survival of 38 weeks is encouraging and further clinical development is warranted.
Patient Care: Phase II data shows promising outcome data of Glioblastoma multiforme patients
Learning Objectives: This phase II study shows promising data results from this novel radioimmunotherapeutic compound in treatment of recurrent high grade gliomas.