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n3:pmcid: PMC0
bibo:doi: 10.1007%2Fs11060-010-0255-0
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Subject Item: _:vb8011703
rdf:type: n8:Section
dc:title: introduction
n8:contains: _:vb8011704 _:vb8011705 _:vb8011706 _:vb8011707 _:vb8011708 _:vb8011709 _:vb8011710 _:vb8011711 _:vb8011712 _:vb8011713

Subject Item: _:vb8011704
rdf:type: n3:Context
rdf:value: The introduction of temozolamide led to prolonged survival of newly diagnosed patients with GBM after radiation and surgical resection to 15 months [>>1<<] but therapeutic options for recurrent GBM are limited.
n3:mentions: n4:11870182

Subject Item: _:vb8011705
rdf:type: n3:Context
rdf:value: regional delivery systems for these patients including convection enhanced delivery (CED) combined with targeted therapy such as cintredekin-besudotox (CB) and TP-38, a recombinant protein targeting the epidermal growth factor receptor [>>2<<, 3]. CB, also referred to as IL13-PE38QQR, has been tested in prior phase I studies using CED as delivery methodology.
n3:mentions: n4:18403491

Subject Item: _:vb8011706
rdf:type: n3:Context
rdf:value: CB, a recombinant cytotoxin composed of the human interleukin -13 (IL-13) and a truncated form of the Pseudomonas aeruginosa Exotoxin A, has been shown to be highly toxic to cells expressing the IL-13 receptor [>>4<<, 5]. Pseudomonas Exotoxin A kills mammalian cells by catalyzing irreversible ADP-ribosylation and inactivation of the elongation factor 2 necessary for protein synthesis. Human GBMs express high levels of the IL-13 receptor in comparison
n3:mentions: n4:7622490

Subject Item: _:vb8011707
rdf:type: n3:Context
rdf:value: CB, a recombinant cytotoxin composed of the human interleukin -13 (IL-13) and a truncated form of the Pseudomonas aeruginosa Exotoxin A, has been shown to be highly toxic to cells expressing the IL-13 receptor [4, >>5<<]. Pseudomonas Exotoxin A kills mammalian cells by catalyzing irreversible ADP-ribosylation and inactivation of the elongation factor 2 necessary for protein synthesis. Human GBMs express high levels of the IL-13 receptor in comparison to
n3:mentions: n4:11291041

Subject Item: _:vb8011708
rdf:type: n3:Context
rdf:value: Human GBMs express high levels of the IL-13 receptor in comparison to normal brain and therefore this genetically engineered drug should be highly specific to tumor cells [>>6<<, 7]. Investigations to assess if CED can successfully distribute IL13-PE38QQR demonstrated that co-infusion of IL13-PE38QQR with 123I-labeled human serum albumin (HAS) in patients with GBM led under ideal circumstances to adequate tissue
n3:mentions: n4:10728667

Subject Item: _:vb8011709
rdf:type: n3:Context
rdf:value: Human GBMs express high levels of the IL-13 receptor in comparison to normal brain and therefore this genetically engineered drug should be highly specific to tumor cells [6, >>7<<]. Investigations to assess if CED can successfully distribute IL13-PE38QQR demonstrated that co-infusion of IL13-PE38QQR with 123I-labeled human serum albumin (HAS) in patients with GBM led under ideal circumstances to adequate tissue
n3:mentions: n4:10946814

Subject Item: _:vb8011710
rdf:type: n3:Context
rdf:value: if CED can successfully distribute IL13-PE38QQR demonstrated that co-infusion of IL13-PE38QQR with 123I-labeled human serum albumin (HAS) in patients with GBM led under ideal circumstances to adequate tissue distribution of the drug [>>8<<]. The authors also identified that proximity to subarachnoid space and placement close to an ependymal surface has a significant detrimental influence on the drug delivery.
n3:mentions: n4:17435179

Subject Item: _:vb8011711
rdf:type: n3:Context
rdf:value: These studies also proved that CB could be infused safely via CED in patients after tumor resection [>>9<<]. The imaging changes seen on MRIs of patients treated with CB via CED are summarized by Parney et al. [10] and a specific scoring system has been established. It is thought that higher grades of imaging changes are due to a necrotic and
n3:mentions: n4:17327604

Subject Item: _:vb8011712
rdf:type: n3:Context
rdf:value: The imaging changes seen on MRIs of patients treated with CB via CED are summarized by Parney et al. [>>10<<] and a specific scoring system has been established.
n3:mentions: n4:15739554

Subject Item: _:vb8011713
rdf:type: n3:Context
rdf:value: have shown that the development of new T2/FLAIR signal abnormalities after delivery of CB via CED is an indication of successful drug delivery using concurrent infusion of CB and 123I-labeled HSA in combination with SPECT analysis [>>11<<]. The encouraging results from prior phase I studies led to the design of the multicenter phase III trial.
n3:mentions: n4:17312057

Subject Item: _:vb8011714
rdf:type: n8:Section
dc:title: materials and methods
n8:contains: _:vb8011716 _:vb8011717 _:vb8011718 _:vb8011715

Subject Item: _:vb8011715
rdf:type: n3:Context
rdf:value: CB was purified as described prior under current good manufacturing practices [>>6<<]. CB was infused at a concentration of 0.5 μg/ml at a total rate of 0.750 ml/h for 96 h after catheter placement was confirmed.
n3:mentions: n4:10728667

Subject Item: _:vb8011716
rdf:type: n3:Context
rdf:value: To visualize these trajectories on all available images, CT and MRI data were overlaid using the image fusion functionality in the iPlan® Flow planning and simulation software, which is described in more detail elsewhere [>>8<<, 13, 14].
n3:mentions: n4:17435179

Subject Item: _:vb8011717
rdf:type: n3:Context
rdf:value: To visualize these trajectories on all available images, CT and MRI data were overlaid using the image fusion functionality in the iPlan® Flow planning and simulation software, which is described in more detail elsewhere [8, >>13<<, 14].
n3:mentions: n4:16709017

Subject Item: _:vb8011718
rdf:type: n3:Context
rdf:value: Imaging change scores were assessed for each catheter as outlined in Table 5 [>>10<<]. Local tumor control was defined as absence of tumor recurrence or progression within 1 cm radius of the trajectory length of the catheter. Local tumor control was assessed for each catheter. Progression was defined as existing tumor
n3:mentions: n4:15739554

Subject Item: _:vb8011719
rdf:type: n8:Section
dc:title: results
n8:contains: _:vb8011720 _:vb8011721 _:vb8011722 _:vb8011723

Subject Item: _:vb8011720
rdf:type: n3:Context
rdf:value: Imaging change score due to CB via CED was graded according to guidelines outlined in Table 5 [>>10<<]. Imaging change scores on both day 43 and day 71 were evaluated for 271 catheters, among which 80% had the same imaging change scores on both days (one-sided 95% lower confidence limit = 76%). The majority of catheters had low to
n3:mentions: n4:15739554

Subject Item: _:vb8011721
rdf:type: n3:Context
rdf:value: The distribution of imaging change score found in our study resembles that previously reported by Kunwar et al. [>>9<<] based on earlier phase I studies using CB at a similar concentration.
n3:mentions: n4:17327604

Subject Item: _:vb8011722
rdf:type: n3:Context
rdf:value: A prior study of patients treated with CB via CED suggested that the development of new T2/FLAIR signal abnormality is associated with drug distribution [>>11<<]. We therefore used the imaging change score as a surrogate for drug distribution in this imaging analysis.
n3:mentions: n4:17312057

Subject Item: _:vb8011723
rdf:type: n3:Context
rdf:value: The composite analysis of prior phase I trials by Kunwar et al. [>>9<<] demonstrated that patients with two or more catheters positioned per guidelines (n = 24) had an improved median survival of 55.6 weeks (95% CI, 21.0–45.9) compared to 37.4 weeks (95% CI, 21.0–45.9) for patients with fewer than two
n3:mentions: n4:17327604

Subject Item: _:vb8011724
rdf:type: n8:Section
dc:title: discussion
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Subject Item: _:vb8011725
rdf:type: n3:Context
rdf:value: As such, the degree of variations in extent of resection may have influenced the study outcome negatively [>>18<<].
n3:mentions: n4:11780887

Subject Item: _:vb8011726
rdf:type: n3:Context
rdf:value: In fact, a recent study based on the experience of the North American Brain Tumor Consortium (NABTC) demonstrates a strong correlation between progression status at 6 months and OS among adult patients with recurrent high grade glioma [>>19<<].
n3:mentions: n4:18356283

Subject Item: _:vb8011727
rdf:type: n3:Context
rdf:value: The median survival in the PRECISE study for patients treated with CB was reported to be 45.3 weeks, which is in concordance with prior studies [>>9<<]. Conversely, the median survival for patients with good catheter scores in the PRECISE trial was significantly lower (39.9 weeks with 95% CI, 32.6–52.4) compared to prior phase I trials (55.6 weeks with 95% CI, 21.0–45.9). In this
n3:mentions: n4:17327604

Subject Item: _:vb8011728
rdf:type: n3:Context
rdf:value: Recently, gadoteridol-loaded liposomes were shown to be successfully delivered in a canine model via CED and this technology also allows for monitoring of the distribution of these particles by real time imaging [>>20<<]. Using this technique, a recent study from Varenika et al. [21] showed that leakage occurred in 20% of infusions in monkeys. The clinical development of such a technique would identify patients in whom leakage occurred during the
n3:mentions: n4:18447717

Subject Item: _:vb8011729
rdf:type: n3:Context
rdf:value: Using this technique, a recent study from Varenika et al. [>>21<<] showed that leakage occurred in 20% of infusions in monkeys.
n3:mentions: n4:18976077

Subject Item: _:vb8011730
rdf:type: n3:Context
rdf:value: With respect to target expression, several studies have shown that the target of CB, the IL-13R, is over-expressed in a large number of high grade glioma explants [>>6<<, 22]. A recent study using a commercially available tissue array and IL-13R antibody showed that up to 75% of patients with GBM over-express the IL-13R. This will allow upfront testing for future trials and should be included in the
n3:mentions: n4:10728667

Subject Item: _:vb8011731
rdf:type: n3:Context
rdf:value: With respect to target expression, several studies have shown that the target of CB, the IL-13R, is over-expressed in a large number of high grade glioma explants [6, >>22<<]. A recent study using a commercially available tissue array and IL-13R antibody showed that up to 75% of patients with GBM over-express the IL-13R. This will allow upfront testing for future trials and should be included in the
n3:mentions: n4:10427128

Subject Item: _:vb8011732
rdf:type: n3:Context
rdf:value: This will allow upfront testing for future trials and should be included in the eligibility criteria [>>23<<]. The percentage of IL13R positive samples within the PRECISE cohort is currently not known and might have influenced the outcome. Heterogeneous expression of the IL-13R has been demonstrated in tumor samples as well as variation in the
n3:mentions: n4:18172271

Subject Item: _:vb8011733
rdf:type: n3:Context
rdf:value: has been demonstrated in tumor samples as well as variation in the expression from various sites of tumor, however the use of different antibodies used in these studies makes it difficult to assess the real impact of these findings [>>6<<, 22–25]. Given that most patients will undergo surgery at recurrence, the expression of the target gene at the tumor margins is much more crucial than the expression in the core of the tumor.
n3:mentions: n4:10728667

Subject Item: _:vb8011734
rdf:type: n3:Context
rdf:value: has been demonstrated in tumor samples as well as variation in the expression from various sites of tumor, however the use of different antibodies used in these studies makes it difficult to assess the real impact of these findings [6, >>22<<–25]. Given that most patients will undergo surgery at recurrence, the expression of the target gene at the tumor margins is much more crucial than the expression in the core of the tumor.
n3:mentions: n4:17804706 n4:18172271 n4:10427128 n4:17004103

Subject Item: _:vb8011735
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rdf:value: We used the imaging change score as a marker for drug distribution based on a study that showed that new FLAIR/T2 signal changes are correlated with drug distribution [>>11<<]. We were unable to identify any correlation between the imaging change score, local tumor control or clinical outcome. The numbers of catheters associated with more extensive imaging changes were relatively low and therefore we might
n3:mentions: n4:17312057

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