Object. The authors conducted a study to assess safety, pain, and quality of life (QOL) outcomes following CyberKnife radiosurgical treatment of spinal tumors. Methods. Data obtained in all patients with spinal tumors who underwent CyberKnife radiosurgery at Georgetown University Hospital between March 2002 and March 2003 were analyzed. Patients underwent examination, visual analog scale (VAS) pain assessment, and completed the 12-item Short Form Health Survey (SF-12) before treatment and at 1, 3, 6, 8, 12, 18, and 24 months following treatment. Fifty-one patients with 72 lesions (58 metastatic and 14 primary) were treated. The mean follow-up period was 1 year. Pain was improved, with the mean VAS score decreasing significantly from 51.5 to 21.3 at 4 weeks (p < 0.001). This effect on pain was durable, with a mean score of 17.5 at 1 year, which was still significantly decreased (p = 0.002). Quality of life was maintained throughout the study period. After 18 months, physical well-being was 33 (initial score 32; p = 0.96) and mental well-being was 43.8 (initial score 44.2; p = 0.97). (The mean SF-12 score is 50 ± 10 [standard deviation].) Adverse effects included self-limited dysphagia (three cases), diarrhea (two cases), lethargy (three cases), paresthesias (one case), and wound dehiscence (one case). Conclusions. CyberKnife radiosurgery improves pain control and maintains QOL in patients treated for spinal tumors. Early adverse events are infrequent and minor. The authors await long-term follow-up data to determine late complications and tumor control rates.

The CED method can be used to deliver AAV capsids and similar sized particles to the CNS safely and effectively over clinically relevant volumes. Moreover, real-time MR imaging of ferumoxtran-10 during infusion reveals that AAV capsids and similar sized particles have different convective delivery properties than smaller proteins and other compounds.

The perfusion of sensitive regions of the rat brain can be accomplished without toxicity by using therapeutic concentrations of carboplatin or gemcitabine. In addition, CED of carboplatin or gemcitabine to tumors in this glioma model is safe and has potent antitumor effects. These findings indicate that similar treatment paradigms may be useful in the treatment of glial neoplasms in humans.

Purpose: To determine if the tumor-targeted cytotoxin interleukin 13 bound to Pseudomonas exotoxin (IL13-PE) could be delivered to the brainstem safely at therapeutic doses while monitoring its distribution in real-time using a surrogate magnetic resonance imaging tracer, we used convection-enhanced delivery to perfuse rat and primate brainstems with IL13-PE and gadolinium-bound albumin (Gd-albumin). Experimental Design: Thirty rats underwent convective brainstem perfusion of IL13-PE (0.25, 0.5, or 10 Ag/mL) or vehicle. Twelve primates underwent convective brainstem perfusion of either IL13-PE (0.25, 0.5, or 10 Ag/mL; n = 8), co-infusion of 125 I-IL13-PE and Gd-albumin (n = 2), or co-infusion of IL13-PE (0.5 Ag/mL) and Gd-albumin (n = 2). The animals were permitted to survive for up to 28 days before sacrifice and histologic assessment. Results: Rats showed no evidence of toxicity at all doses. Primates showed no toxicity at 0.25 or 0.5 Ag/mL but showed clinical and histologic toxicity at 10 Ag/mL. Quantitative autoradiography confirmed that Gd-albumin precisely tracked IL13-PE anatomic distribution and accurately showed the volume of distribution. Conclusions: IL13-PE can be delivered safely and effectively to the primate brainstem at therapeutic concentrations and over clinically relevant volumes using convection-enhanced delivery. Moreover, the distribution of IL13-PE can be accurately tracked by co-infusion of Gd-albumin using real-time magnetic resonance imaging.