Future of convection-enhanced delivery in the treatment of brain tumors

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Bibliography

• 1  Gralow J, Ozols RF, Bajorin DF et al.: Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening – a report from the American Society of Clinical Oncology. J. Clin. Oncol.26(2),313–325 (2008).
  MedlineGoogle Scholar
• 2  Dandy WE: Removal of right cerebral hemisphere for certain tumors with hemiplegia. JAMA90,823–825 (1928).
  Google Scholar
• 3  Bobo RH, Laske DW, Akbasak A et al.: Convection-enhanced delivery of macromolecules in the brain. Proc. Natl Acad. Sci. USA91(6),2076–2080 (1994).▪▪ First article to describe the use of low, continuous, positive pressure infusion for the delivery of drugs and other macromolecules into the brain, and includes a mathematical description of the convection process.
  Medline CASGoogle Scholar
• 4  Hall WA, Sherr GT: Convection-enhanced delivery of targeted toxins for malignant glioma. Expert Opin. Drug Deliv.3,371–377 (2006).
  Medline CASGoogle Scholar
• 5  Raghavan R, Brady ML, Rodriquez-Ponce MI, Hartlep A, Pedain C, Sampson JH: Convection-enhanced delivery of therapeutics for brain disease, and its optimization. Neurosurg. Focus20(4),E12 (2006).
  MedlineGoogle Scholar
• 6  Laske DW, Youle RJ, Oldfield EH: Tumor regression with regional distribution of the targeted toxin TF-CRM107 in patients with malignant brain tumors. Nat. Med.3(12),1362–1368 (1997).▪ One of the first reports to show the potential clinical benefit associated with convection-enhanced delivery (CED) of a targeted therapeutic molecule for the treatment of patients with gliomas.
  Medline CASGoogle Scholar
• 7  Weaver M, Laske DW: Transferrin receptor ligand-targeted toxin conjugate (Tf-CRM107) for therapy of malignant gliomas. J. Neurooncol.65(1),3–13 (2003).
  MedlineGoogle Scholar
• 8  Patel SJ, Shapiro WR, Laske DW et al.: Safety and feasibility of convection-enhanced delivery of Cotara for the treatment of malignant glioma: initial experience in 51 patients. Neurosurgery56(6),1243–1252 (2005).
  MedlineGoogle Scholar
• 9  Debinski W, Obiri NI, Pastan I, Puri RK: A novel chimeric protein composed of interleukin 13 and Pseudomonas exotoxin is highly cytotoxic to human carcinoma cells expressing receptors for interleukin 13 and interleukin 4. J. Biol. Chem.270(28),16775–16780 (1995).
  Medline CASGoogle Scholar
• 10  Puri RK, Mehrotra PT, Lelan P, Kreitman RJ, Siegel JP, Pastan I: A chimeric protein comprised of IL-4 and Pseudomonas exotoxin is cytotoxic for activated human lymphocytes. J. Immunol.152(7),3693–3700 (1994).
  Medline CASGoogle Scholar
• 11  Kawakami M, Kawakami K, Puri RK: Interleukin-4-pseudomonas exotoxin chimeric fusion protein for malignant glioma therapy. J. Neurooncol.65(1),15–25 (2003).
  MedlineGoogle Scholar
• 12  Rand RW, Keritman RJ, Patronas N, Varricchio F, Pastan I, Puri RK: Intratumoral administration of recombinant circularly permuted interleukin-4-Pseudomonas exotoxin in patients with high-grade glioma. Clin. Cancer Res.6(6),2157–2165 (2000).
  Medline CASGoogle Scholar
• 13  Weber FW, Floeth F, Asher A et al.: Local convection enhanced delivery of IL4-Pseudomonas exotoxin (NBI-3001)for treatment of patients with recurrent malignant glioma. Acta Neurochir. Supp.88,93–103 (2003).
  Medline CASGoogle Scholar
• 14  Weber F, Asher A, Bucholz R et al.: Safety, tolerability, and tumor response of IL4-Pseudomonas exotoxin (NBI-3001) in patients with recurrent malignant glioma. J. Neurooncol.64(1–2),125–137.
  MedlineGoogle Scholar
• 15  Mardor Y, Last D, Daniels D et al.: Convection enhanced delivery of IL-4 Pseudomonas exotoxin (PRX321): increased distribution and MR monitoring. J. Pharmacol. Exp. Ther.330(2),520–525 (2009).
  Medline CASGoogle Scholar
• 16  Sampson JH, Akabani G, Archer GE et al.: Intracerebral infusion of an EGFR-targeted toxin in recurrent malignant brain tumors. Neuro Oncol.10,320–329 (2008).
  Medline CASGoogle Scholar
• 17  Kunwar S, Prados MD, Chang SM et al.: Intracerebral delivery of cintredekin besudotox (IL13-PE38QQR) in recurrent malignant glioma: a report by the Cintredekin Besudotox Intraparenchymal Study Group. J. Clin. Oncol.25(7),837–844 (2007).
  Medline CASGoogle Scholar
• 18  Sampson JH, Raghavan R, Provenzale JM et al.: Induction of hyperintense signal on T2-weighted MR images correlates with infusion distribution from intracerebral convection-enhanced delivery of a tumor-targeted cytotoxin. AJR Am. J. Roentgenol.188(3),703–709 (2007).
  MedlineGoogle Scholar
• 19  Sampson JH, Brady ML, Petry NA et al.: Intracerebral infusated distribution by convection-enhanced delivery in humans with malignant gliomas: descriptive effects of target anatomy and catheter positioning. Neurosurgery60(2 Suppl. 1),ONS89–ONS98 (2007).
  MedlineGoogle Scholar
• 20  Sampson JH, Raghavan R, Brady ML et al.: Clinical utility of a patient-specific algorithm for simulating intracerebral drug infusions. Neuro Oncol.9(3),343–353 (2007).▪ Demonstrates the first use of a patient-specific, computationally-based predictive model of drug distribution by CED in the clinical setting.
  Medline CASGoogle Scholar
• 21  Kunwar S, Westphal M, Medhorn M et al.: Results from PRECISE: a randomized Phase 3 study in patients with first recurrent glioblastoma multiforme (GBM) comparing cintredekin besudotox (CB) administered via convection-enhanced delivery (CED) with gliadel wafers (GW). Presented at: 12th Annual Meeting of the Society for Neuro-Oncology, 15–18 November 2007, Dallas, TX, USA.▪▪ Documents the results of the first completed Phase III trial for the treatment of glioblastoma with use of CED.
  Google Scholar
• 22  Vogelbaum MA, Sampson JH, Kunwar S et al.: Convection-enhanced delivery of cintredekin besudotox (interleuking-13-PE38QQR) followed by radiation therapy with and without temozolomide in newly diagnosed malignant gliomas: Phase 1 study of final safety results. Neurosurgery61(5),1031–1037 (2007).
  MedlineGoogle Scholar
• 23  Lidar Z, Mardor Y, Jonas T et al.: Convection-enhanced delivery of paclitaxel for the treatment of recurrent malignant glioma: a Phase I/II clinical study. J. Neurosurg.100,472–479 (2004).
  Medline CASGoogle Scholar
• 24  Bruce JN, Fine RL, Canoll P, Sisti MB et al.: Phase I trial of topotecan by convection enhanced delivery for recurrent malignant gliomas. Presented at: 2009 AANS National Meeting. 2–6 May 2009, Chicago, IL, USA.
  Google Scholar
• 25  Schlingensiepen KH, Fischer-Blass B, Schmaus, S et al.: Antisense therapeutics for tumor treatment: the TGF-β 2 inhibitor AP 12009 in clinical development against malignant tumors. Recent Results Cancer Res.177,137–150 (2008).
  Medline CASGoogle Scholar
• 26  Vallera DA, Li Chunbin, Jin N, Panoskaltsis-Mortari A, Hall WA: Targeting urokinase-type plasminogen activator receptor on human glioblastoma tumors with diphtheria toxin fusion protein DTAT. J. Natl Cancer Inst.94(8),597–606 (2002).
  Medline CASGoogle Scholar
• 27  Hall WA, Vallera DA: Efficacy of antiangiogenic targeted toxins against glioblastoma multiforme. Neurosurg. Focus20(4),E23 (2006).
  MedlineGoogle Scholar
• 28  Rustamzadeh E, Hall WA, Todhunter DA et al.: Intracranial therapy of glioblastoma with the fusion protein DTAT in immunodeficient mice. Int. J. Cancer120(2),411–419 (2007).
  Medline CASGoogle Scholar
• 29  Lieberman DM, Laske DW, Morrison PF, Bankiewicz KS, Oldfield EH: Convection-enhanced distribution of large molecules in gray matter during interstitial drug infusion. J. Neurosurg.82,1021–1029 (1995).
  Medline CASGoogle Scholar
• 30  Morrison PF, Chen MY, Chadwick RS, Lonser RR, Oldfield EH: Focal delivery during direct infusion to brain: role of flow rate, catheter diameter, and tissue mechanics. Am. J. Physiol.277,1218–1229 (1999).▪▪ Describes many of the issues we continue to face regarding the catheter–brain interface and avoidance of backflow and infusate ‘dumping’ into cerebrospinal fluid spaces.
  Google Scholar
• 31  Krauze MT, Saito R, Noble C et al.: Reflux-free cannula for convection-enhanced high-speed delivery of therapeutic agents. J. Neurosurg.103,923–929 (2005).▪ One of the earliest descriptions of a novel catheter design that may help overcome the problem of infusate backflow (reflux) around the infusion catheter.
  MedlineGoogle Scholar
• 32  Oh S, Odland R, Wilson S et al.: Improved distribution of small molecules and viral vectors in the murine brain using a hollow fiber catheter. J. Neurosurg.107,568–577 (2007).
  MedlineGoogle Scholar
• 33  Grahn AY, Bankiewicz KS, Dugich-Djordjevic M et al.: Non-PEGylated liposomes for convection-enhanced delivery of topotecan and gadodiamide in malignant glioma: initial experience. J. Neurooncol.95(2),185–197 (2009).
  Medline CASGoogle Scholar
• 34  Huwyler J, Wu D, Pardridge WM: Brain drug delivery of small molecules using immunoliposomes. Proc. Natl Acad. Sci. USA93,14164–14169 (1996).
  Medline CASGoogle Scholar
• 35  Kreuter J: Nanoparticles: In: Encyclopedia of pharmaceutical technology (Volume 10). Swarbrick J, Boylan JC (Eds). Marcel Dekker, NY, USA, 165–190 (1994).
  Google Scholar
• 36  Gelperina SE, Smirnova ZS, Khalanskiy AS, Skidan IN, Bobruskin AI, Kreuter J: Chemotherapy of brain tumors using doxorubicin bound to polysorbate 80-coated nanoparticles. Proceedings of the 3^rd World Meeting APV/APGI. Berlin, Germany 2000. 3-6 April 2000, 441–442 (2003).
  Google Scholar
• 37  Rogawski MA: Convection-enhanced delivery in the treatment of epilepsy. Neurotherapeutics6,344–351 (2009).
  Medline CASGoogle Scholar
• 38  Varenika V, Dickinson P, Bringas, J et al.: Detection of infusate leakage in the brain using real-time imaging of convection-enhanced delivery. J. Neurosurg.109,874–880 (2008).
  MedlineGoogle Scholar
• 39  Mardor Y, Rahav O, Zauberman Y et al.: Convection-enhanced drug delivery: increased efficacy and magnetic resonance image monitoring. Cancer Res.65,6858–6863 (2005).
  Medline CASGoogle Scholar
• 40  Krauze MT, Forsayeth J, Park JW, Bankiewicz KS: Real-time imaging and quantification of brain delivery of liposomes. Pharm. Res.23,2493–2504 (2006).
  Medline CASGoogle Scholar
• 41  Krauze MT, McKnight TR, Yamashita Y et al.: Real-time visualization and characterization of liposomal delivery into the monkey brain by magnetic resonance imaging. Brain Res. Protoc.16,20–26 (2005).▪▪ Demonstrates the value of co-infusion of an imaging tracer with a therapeutic molecule to document the extent of drug delivery in the brain. This approach will allow for documentation of treatment ‘isodoses’ within the target tissue.
  Medline CASGoogle Scholar
• 42  Saito R, Krauze MT, Bringas JR et al.: Gadolinium-loaded liposomes allow for real-time magnetic resonance imaging of convection-enhanced delivery in the primate brain. Exp. Neurol.196,381–389 (2005).
  Medline CASGoogle Scholar
• 43  Croteau D, Walbridge S, Morrison PF et al.: Real-time in vivo imaging of the convective distribution of a low-molecular-weight tracer. J. Neurosurg.102,90–97 (2005).
  MedlineGoogle Scholar
• 44  Mardor Y, Roth Y, Lidar Z et al.: Monitoring response to convection-enhanced taxol delivery in brain tumor patients using diffusion-weighted magnetic resonance imaging. Cancer Res.61,4971–4973 (2001).
  Medline CASGoogle Scholar
• 45  Regino CA, Walbridge S, Bernardo M et al.: A dual CT-MR dendrimer contrast agent as a surrogate marker for convection-enhanced delivery of intracerebral macromolecular therapeutic agents. Contrast Media Mol. Imaging3,2–8 (2008).
  Medline CASGoogle Scholar
• 46  Voges J, Reszka R, Gossmann A et al.: Imaging-guided convection-enhanced delivery and gene therapy of glioblastoma. Ann. Neurol.54,479–487 (2003)▪ Demonstrates that co-infusion directly into the brain of a commonly used, gadolinium- based MRI contrast agent is safe in humans and can document the delivery of a therapeutic agent.
  Medline CASGoogle Scholar