Safety of intraparenchymal convection-enhanced delivery of cintredekin besudotox in early-phase studies.

Abstract:

OBJECT:Convection-enhanced delivery (CED) is an increasingly used novel local/regional delivery method targeted directly to tissue. It relies on a continuous pressure gradient for distribution of therapeutic agents into the interstitial space, with administration of the infusate over a few days. Cintredekin besudotox (also known as IL13- PE38QQR) is a recombinant chimeric cytotoxin consisting of interleukin-13 and a truncated exotoxin produced by the Pseudomonas aeruginosa bacterium, which targets malignant glioma cells. METHODS:Cintredekin besudotox was administered via intraparenchymal CED after resection of supratentorial recurrent malignant glioma. The safety and toxicity profile was reviewed for 53 patients in whom infusion catheters had been placed; 51 of them received CED of the study drug. Adverse events were categorized based on time of onset in relation to CED, and the causal relationship with catheter placement or delivery of cintredekin besudotox. Catheters were placed in 53 patients, although only 51 of them received cintredekin besudotox. Most adverse events related to catheter placement or the study drug originated from the central nervous system. Three symptomatic windows were defined: the first one was between surgical procedure and CED; the second was during CED and up to 1 week after its completion; and the third window was 2 to 10 weeks after treatment. Those windows generally reflected adverse events related to surgical procedures, mass effect from infusate, and drug effect on tumor-infiltrated and normal brain parenchyma, respectively. CONCLUSIONS:The symptomatic windows identified in this study apply to any CED clinical trials, particularly those in which chimeric cytotoxins are used, and will help to determine the most likely underlying pathophysiological process causing symptoms. This information, in turn, will help to prevent adverse events or minimize their severity. Those events also have implications for dose escalation and outcome measures.

journal_name

Neurosurg Focus

journal_title

Neurosurgical focus

authors

Kunwar S,Chang SM,Prados MD,Berger MS,Sampson JH,Croteau D,Sherman JW,Grahn AY,Shu VS,Dul JL,Husain SR,Joshi BH,Pedain C,Puri RK

subject

Has Abstract

pub_date

2006-04-15 00:00:00

pages

E15

issue

4

issn

1092-0684

pii

200415

journal_volume

20

pub_type

临床试验,杂志文章
  • Determination of filling volumes in HydroCoil-treated aneurysms by using three-dimensional computerized tomography angiography.

    abstract:OBJECT:Coil embolization of aneurysms has been shown to be as safe and effective as surgical clip ligation, but has a higher recurrence rate. Advances in coil technology aim to reduce aneurysm recurrence by coating the devices with biological substances. An example of this is MicroVention's HydroCoil, which is a platin...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/foc.2005.18.2.6

    authors: Deshaies EM,Bagla S,Agner C,Boulos AS

    更新日期:2005-02-15 00:00:00

  • The influence of secondary gain on surgical outcome: a comparison between cervical and lumbar discectomy.

    abstract::Although the expectation of monetary compensation has been associated with failures in lumbar discectomy, the issue has not been investigated in patients undergoing cervical disc surgery. The authors analyzed the relationship between economic forms of secondary gain and surgical outcome in a group of patients with a c...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/foc.1998.5.2.9

    authors: Kaptain GJ,Shaffrey CI,Alden TD,Young JN,Whitehill R

    更新日期:1998-08-15 00:00:00

  • Hydrocephalus: the role of cerebral aquaporin-4 channels and computational modeling considerations of cerebrospinal fluid.

    abstract::Aquaporin-4 (AQP4) channels play an important role in brain water homeostasis. Water transport across plasma membranes has a critical role in brain water exchange of the normal and the diseased brain. AQP4 channels are implicated in the pathophysiology of hydrocephalus, a disease of water imbalance that leads to CSF a...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2016.7.FOCUS16191

    authors: Desai B,Hsu Y,Schneller B,Hobbs JG,Mehta AI,Linninger A

    更新日期:2016-09-01 00:00:00

  • Clinical relevance of short-term follow-up of unruptured intracranial aneurysms.

    abstract:OBJECTIVE:Unruptured intracranial aneurysms are common incidental findings on brain imaging. Short-term follow-up for conservatively treated aneurysms is routinely performed in most cerebrovascular centers, although its clinical relevance remains unclear. In this study, the authors assessed the extent of growth as well...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2019.4.FOCUS1995

    authors: Molenberg R,Aalbers MW,Metzemaekers JDM,Mazuri A,Luijckx GJ,Groen RJM,Uyttenboogaart M,van Dijk JMC

    更新日期:2019-07-01 00:00:00

  • A stepwise illustration of the retrosigmoid approach for resection of a cerebellopontine meningioma.

    abstract::The retrosigmoid approach is a work-horse approach to the cerebellopontine angle (CPA), providing access from the foremen magnum to the tentorium. Indications for this approach are variable such as resection of meningiomas, acoustic neuromas and epidermoid tumors, treatment of vascular lesions of vertebrobasilar syste...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2014.V1.FOCUS13445

    authors: Cıkla U,Kujoth GC,Başkaya MK

    更新日期:2014-01-01 00:00:00

  • Pathophysiology of adult tethered cord syndrome: review of the literature.

    abstract:OBJECT:Tethering of the spinal cord has been a recognized cause of neurological symptoms in pediatric patients and is increasingly being recognized as a cause of symptoms in adults as well. The pathophysiology surrounding spinal cord tethering has begun to be understood in the pediatric population but is still unclear ...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2010.3.FOCUS1080

    authors: Stetler WR Jr,Park P,Sullivan S

    更新日期:2010-07-01 00:00:00

  • 5-ALA-induced fluorescence as a marker for diagnostic tissue in stereotactic biopsies of intracranial lymphomas: experience in 41 patients.

    abstract::OBJECTIVE Stereotactic needle biopsies are usually performed for histopathological confirmation of intracranial lymphomas to guide adequate treatment. During biopsy, intraoperative histopathology is an effective tool to avoid acquisition of nondiagnostic samples. In the last years, 5-aminolevulinic acid (5-ALA)-induce...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2018.3.FOCUS1859

    authors: Kiesel B,Millesi M,Woehrer A,Furtner J,Bavand A,Roetzer T,Mischkulnig M,Wolfsberger S,Preusser M,Knosp E,Widhalm G

    更新日期:2018-06-01 00:00:00

  • Spinal cord injury and the human microbiome: beyond the brain-gut axis.

    abstract::In addition to standard management for the treatment of the acute phase of spinal cord injury (SCI), implementation of novel neuroprotective interventions offers the potential for significant reductions in morbidity and long-term health costs. A better understanding of the systemic changes after SCI could provide insi...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2018.12.FOCUS18206

    authors: Wallace DJ,Sayre NL,Patterson TT,Nicholson SE,Hilton D,Grandhi R

    更新日期:2019-03-01 00:00:00

  • Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

    abstract::The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinate...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2020.2.FOCUS207

    authors: Asher AL,Knightly J,Mummaneni PV,Alvi MA,McGirt MJ,Yolcu YU,Chan AK,Glassman SD,Foley KT,Slotkin JR,Potts EA,Shaffrey ME,Shaffrey CI,Haid RW,Fu KM,Wang MY,Park P,Bisson EF,Harbaugh RE,Bydon M

    更新日期:2020-05-01 00:00:00

  • Endoscopic endonasal resection of skull base meningiomas: the significance of a "cortical cuff" and brain edema compared with careful case selection and surgical experience in predicting morbidity and extent of resection.

    abstract:OBJECT:This paper describes a consecutive series of skull base meningiomas resected using an endoscopic endonasal approach through various corridors at a single institution over 7 years. The impact of case selection and experience, the presence of a cortical cuff between the tumor and surrounding vessels, and brain ede...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2014.7.FOCUS14321

    authors: Khan OH,Anand VK,Schwartz TH

    更新日期:2014-01-01 00:00:00

  • Robotic versus fluoroscopy-guided pedicle screw insertion for metastatic spinal disease: a matched-cohort comparison.

    abstract::OBJECTIVE Robot-guided pedicle screw placement is an established technique for the placement of pedicle screws. However, most studies have focused on degenerative disease. In this paper, the authors focus on metastatic spinal disease, which is associated with osteolysis. The associated lack of dense bone may potential...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2017.3.FOCUS1710

    authors: Solomiichuk V,Fleischhammer J,Molliqaj G,Warda J,Alaid A,von Eckardstein K,Schaller K,Tessitore E,Rohde V,Schatlo B

    更新日期:2017-05-01 00:00:00

  • The far-lateral approach for foramen magnum meningiomas.

    abstract::Foramen magnum meningiomas (FMMs) are slow growing, most often intradural and extramedullary tumors that pose significant challenges to the skull base neurosurgeon. The indolent clinical course of FMMs and their insidious onset of symptoms are important factors that contribute to delayed diagnosis and relative large s...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2013.10.FOCUS13332

    authors: Flores BC,Boudreaux BP,Klinger DR,Mickey BE,Barnett SL

    更新日期:2013-12-01 00:00:00

  • Hemorrhage of cavernous malformations during pregnancy and in the peripartum period: causal or coincidence? Case report and review of the literature.

    abstract::There is growing evidence to suggest that pregnancy may increase the risk of hemorrhage from cavernous malformations (CMs). In the present case, a 21-year-old primigravida was admitted to the authors' neurosurgical service after a cesarean section. Three weeks before admission she had experienced rapidly progressive b...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/foc.2006.21.1.13

    authors: Safavi-Abbasi S,Feiz-Erfan I,Spetzler RF,Kim L,Dogan S,Porter RW,Sonntag VK

    更新日期:2006-07-15 00:00:00

  • The role of cell therapy for stroke.

    abstract::Cellular therapy has been evaluated in small animals, subhuman primates, and now humans for the potential repair of brain injury due to stroke. Experimental striate stroke models have proven useful for the purpose of evaluating different treatment paradigms. Early clinical trials involving neuronal transplantation in ...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/foc.2002.13.5.2

    authors: Kondziolka D,Wechsler L,Tyler-Kabara E,Achim C

    更新日期:2002-11-15 00:00:00

  • Imaging of primary central nervous system lymphoma.

    abstract::Primary central nervous system lymphoma (PCNSL) is an aggressive neoplastic process that occurs in both immunocompetent and immunocompromised patients. Over the past 30 years there has been a steady increase in the number of cases in both patient populations. The imaging features for the disease and demographic charac...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/foc.2006.21.5.5

    authors: Go JL,Lee SC,Kim PE

    更新日期:2006-11-15 00:00:00

  • Biomechanics of the posterior lumbar articulating elements.

    abstract::The clinical success of lumbar spinal fusion varies considerably, depending on techniques and indications. Although spinal fusion generally helps to eliminate certain types of pain, it may also decrease function by limiting patient mobility. Furthermore, spinal fusion may increase stresses on adjacent nonfused motion ...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/foc.2007.22.1.1

    authors: Serhan HA,Varnavas G,Dooris AP,Patwadhan A,Tzermiadianos M

    更新日期:2007-01-15 00:00:00

  • Endovascular management of cerebral venous sinus thrombosis.

    abstract::Cerebral venous sinus thrombosis (CVST) is characterized by formation of widespread thrombus within the cerebral venous sinus system. CVST can cause venous hypertension, venous infarcts, hemorrhage and seizures. It is managed in most cases with systemic anticoagulation through the use of heparin to resolve the thrombu...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2014.V2.FOCUS14186

    authors: Choudhri O,Feroze A,Marks MP,Do HM

    更新日期:2014-07-01 00:00:00

  • The medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the United States.

    abstract::Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentatio...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2020.8.FOCUS20600

    authors: Sankey EW,Mehta VA,Wang TY,Than TT,Goodwin CR,Karikari IO,Shaffrey CI,Abd-El-Barr MM,Than KD

    更新日期:2020-11-01 00:00:00

  • Extracranial-intracranial bypass approach to cerebral revascularization: a historical perspective.

    abstract::While the majority of cerebral revascularization advancements were made in the last century, it is worth noting the humble beginnings of vascular surgery throughout history to appreciate its progression and application to neurovascular pathology in the modern era. Nearly 5000 years of basic human inquiry into the vasc...

    journal_title:Neurosurgical focus

    pub_type: 历史文章,杂志文章

    doi:10.3171/2018.11.FOCUS18527

    authors: Soldozy S,Costello JS,Norat P,Sokolowski JD,Soldozy K,Park MS,Tvrdik P,Kalani MYS

    更新日期:2019-02-01 00:00:00

  • Positional plagiocephaly: an analysis of the literature on the effectiveness of current guidelines.

    abstract:OBJECT:Positional plagiocephaly (PP) has been on the rise in recent years. In this review, the authors' aim was to assess the effectiveness of current recommendations to parents on this exceedingly common problem through a comprehensive literature search. Additionally, the current treatment options and the most recent ...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,meta分析,评审

    doi:10.3171/2013.8.FOCUS13261

    authors: Shweikeh F,Nuño M,Danielpour M,Krieger MD,Drazin D

    更新日期:2013-10-01 00:00:00

  • Retropleural thoracotomy. Technical note.

    abstract::Herniated thoracic discs, unlike their lumbar counterparts, are difficult to read and safely resect using traditional posterior approaches. Historically, the use of a laminectomy for thoracic disc resection has yielded poor clinical outcomes. Posterolateral and anterolateral approaches have become the standard surgica...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/foc.2001.10.1.9

    authors: Angevin PD,McCormick PC

    更新日期:2001-01-15 00:00:00

  • Distribution and stability of antisense phosphorothioate oligonucleotides in rodent brain following direct intraparenchymal controlled-rate infusion.

    abstract::High-flow microinfusion is a novel technique for delivery of compounds directly into the brain parenchyma, bypassing the blood-brain barrier. The feasibility of this technique has been demonstrated with low-molecular-weight compounds, macromolecular dyes, and proteins. Delivery of antisense oligonucleotides into the b...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/foc.1997.3.5.7

    authors: Broaddus WC,Prabhu SS,Gillies GT,Neal J,Conrad WS,Chen ZJ,Fillmore H,Young HF

    更新日期:1997-11-15 00:00:00

  • Role of the neurofibromatosis type 2 gene in the development of tumors of the nervous system.

    abstract::Germ line and somatic mutations in the neurofibromatosis Type 2 (NF2) tumor suppressor gene predispose individuals to tumors of the nervous system, including schwannomas and meningiomas. Since identification of the NF2 gene more than a decade ago, a large body of information has been collected on the nature and conseq...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/foc.2005.19.5.7

    authors: Ruttledge MH,Rouleau GA

    更新日期:2005-11-15 00:00:00

  • J. Lawrence Pool, M.D.: a pioneer in vascular neurosurgery.

    abstract::The authors detail the life and career of Dr. J. Lawrence Pool, as well as his significant contributions to the field of cerebrovascular neurosurgery. The discipline of cerebrovascular neurosurgery is a young and dynamic field, which underwent rapid and substantial growth during the middle of the twentieth century. As...

    journal_title:Neurosurgical focus

    pub_type: 传,历史文章,杂志文章

    doi:

    authors: Zacharia BE,Mocco J,Komotar RJ,Solomon RA,Quest DO

    更新日期:2006-06-15 00:00:00

  • Atypical tumors of the facial nerve: case series and review of the literature.

    abstract:OBJECT:The authors present a series of 4 patients with rare facial nerve tumors. The relevant literature is reviewed and is discussed regarding diagnostic features, the role of operative management, and surgical approach. METHODS:A retrospective chart review was conducted for patients with tumors of the facial nerve t...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2013.1.FOCUS12380

    authors: Ross L,Drazin D,Eboli P,Lekovic GP

    更新日期:2013-03-01 00:00:00

  • An historical context of modern principles in the management of intracranial injury from projectiles.

    abstract::The contemporary management of projectile head injuries owes much to the lessons neurosurgeons have distilled from their experiences in war. Through early investigation and an increasingly detailed account of wartime clinical experience, neurosurgeons--including the field's early giants--began to gain a greater unders...

    journal_title:Neurosurgical focus

    pub_type: 历史文章,杂志文章

    doi:10.3171/2010.2.FOCUS1038

    authors: Agarwalla PK,Dunn GP,Laws ER

    更新日期:2010-05-01 00:00:00

  • Transzygomatic extended middle fossa approach for upper petroclival skull base lesions.

    abstract::Central skull base lesions in the upper retroclival and petroclival regions can be challenging to access because of their location anterior to the brainstem. Several transpetrosal approaches have been developed to access the petroclival junction, including anterior petrosal (anterior petrosectomy), posterior petrosal ...

    journal_title:Neurosurgical focus

    pub_type: 临床试验,杂志文章

    doi:10.3171/FOC.2008.25.12.E5

    authors: Zhao JC,Liu JK

    更新日期:2008-01-01 00:00:00

  • Endovascular delivery of leads and stentrodes and their applications to deep brain stimulation and neuromodulation: a review.

    abstract::Neuromodulation and deep brain stimulation (DBS) have been increasingly used in many neurological ailments, including essential tremor, Parkinson's disease, epilepsy, and more. Yet for many patients and practitioners the desire to utilize these therapies is met with caution, given the need for craniotomy, lead inserti...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2018.4.FOCUS18130

    authors: Rajah G,Saber H,Singh R,Rangel-Castilla L

    更新日期:2018-08-01 00:00:00

  • Molecular and cellular heterogeneity: the hallmark of glioblastoma.

    abstract::There has been increasing awareness that glioblastoma, which may seem histopathologically similar across many tumors, actually represents a group of molecularly distinct tumors. Emerging evidence suggests that cells even within the same tumor exhibit wide-ranging molecular diversity. Parallel to the discoveries of mol...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章,评审

    doi:10.3171/2014.9.FOCUS14521

    authors: Aum DJ,Kim DH,Beaumont TL,Leuthardt EC,Dunn GP,Kim AH

    更新日期:2014-12-01 00:00:00

  • Trends in neurosurgical care in Western Uganda: an interrupted time series analysis.

    abstract:OBJECTIVE:In addition to the rising burden of surgical disease globally, infrastructure and human resources for health remain a great challenge for low- and middle-income countries, especially in Uganda. In this study, the authors aim to explore the trends of neurosurgical care at a regional referral hospital in Uganda...

    journal_title:Neurosurgical focus

    pub_type: 杂志文章

    doi:10.3171/2018.7.FOCUS18270

    authors: Abdelgadir J,Elahi C,Corley J,Wall KC,Najjuma JN,Muhindo A,Nickenig Vissoci JR,Haglund MM,Kitya D

    更新日期:2018-10-01 00:00:00