Magnetic Resonance Imaging–Based Assessment of Gadolinium-Conjugated Diethylenetriamine Penta-Acetic Acid Test-Infusion in Detecting Dysfunction of Convection-Enhanced Delivery Catheters

Putten, Erik H.P. van; Wembacher-Schröder, Eva; Smits, Marion; Dirven, Clemens M.F.

doi:10.1016/j.wneu.2016.02.003

Cited by 11 publications

(8 citation statements)

References 16 publications

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“…Because gadolinium contrast was removed from the study, a visual assessment of all catheter infusion performance could not be undertaken. However, it is likely that infusion coverage performance was high and consistent, as seen in the first two patients, and unaffected by the presence of these transient events, similar to a previous report 41 …”

Section: Discussionsupporting

confidence: 87%

Intraputamenal Cerebral Dopamine Neurotrophic Factor in Parkinson's Disease: A Randomized, Double‐Blind, Multicenter Phase 1 Trial

et al. 2023

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Background Cerebral dopamine neurotrophic factor (CDNF) is an unconventional neurotrophic factor that protects dopamine neurons and improves motor function in animal models of Parkinson's disease (PD). Objective The primary objectives of this study were to assess the safety and tolerability of both CDNF and the drug delivery system (DDS) in patients with PD of moderate severity. Methods We assessed the safety and tolerability of monthly intraputamenal CDNF infusions in patients with PD using an investigational DDS, a bone‐anchored transcutaneous port connected to four catheters. This phase 1 trial was divided into a placebo‐controlled, double‐blind, 6‐month main study followed by an active‐treatment 6‐month extension. Eligible patients, aged 35 to 75 years, had moderate idiopathic PD for 5 to 15 years and Hoehn and Yahr score ≤ 3 (off state). Seventeen patients were randomized to placebo (n = 6), 0.4 mg CDNF (n = 6), or 1.2 mg CDNF (n = 5). The primary endpoints were safety and tolerability of CDNF and DDS and catheter implantation accuracy. Secondary endpoints were measures of PD symptoms, including Unified Parkinson's Disease Rating Scale, and DDS patency and port stability. Exploratory endpoints included motor symptom assessment (PKG, Global Kinetics Pty Ltd, Melbourne, Australia) and positron emission tomography using dopamine transporter radioligand [18F]FE‐PE2I. Results Drug‐related adverse events were mild to moderate with no difference between placebo and treatment groups. No severe adverse events were associated with the drug, and device delivery accuracy met specification. The severe adverse events recorded were associated with the infusion procedure and did not reoccur after procedural modification. There were no significant changes between placebo and CDNF treatment groups in secondary endpoints between baseline and the end of the main and extension studies. Conclusions Intraputamenally administered CDNF was safe and well tolerated, and possible signs of biological response to the drug were observed in individual patients. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

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Section: Discussionsupporting

confidence: 87%

Intraputamenal Cerebral Dopamine Neurotrophic Factor in Parkinson's Disease: A Randomized, Double‐Blind, Multicenter Phase 1 Trial

et al. 2023

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“…Seven patients had a long-term survival of over 24 months and no Grade 3 or greater adverse events occurred (59,89). Another phase I trial demonstrated safety in patients treated with AdDelta24-RGD through convection enhanced delivery (CED), an intratumoral delivery using continuous, low-positivepressure bulk flow to deliver drugs through the implantation of catheters (90)(91)(92). AdDelta24-RGD is currently studied as a combination therapy in multiple phase I and II studies (NCT01956734, NCT02197169, NCT02798406).…”

Section: Adenovirusmentioning

confidence: 99%

Oncolytic Viro-Immunotherapy: An Emerging Option in the Treatment of Gliomas

Zeng

Sander³

et al. 2021

Front. Immunol.

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The prognosis of malignant gliomas remains poor, with median survival fewer than 20 months and a 5-year survival rate merely 5%. Their primary location in the central nervous system (CNS) and its immunosuppressive environment with little T cell infiltration has rendered cancer therapies mostly ineffective, and breakthrough therapies such as immune checkpoint inhibitors (ICIs) have shown limited benefit. However, tumor immunotherapy is developing rapidly and can help overcome these obstacles. But for now, malignant gliomas remain fatal with short survival and limited therapeutic options. Oncolytic virotherapy (OVT) is a unique antitumor immunotherapy wherein viruses selectively or preferentially kill tumor cells, replicate and spread through tumors while inducing antitumor immune responses. OVTs can also recondition the tumor microenvironment and improve the efficacy of other immunotherapies by escalating the infiltration of immune cells into tumors. Some OVTs can penetrate the blood-brain barrier (BBB) and possess tropism for the CNS, enabling intravenous delivery. Despite the therapeutic potential displayed by oncolytic viruses (OVs), optimizing OVT has proved challenging in clinical development, and marketing approvals for OVTs have been rare. In June 2021 however, as a genetically engineered OV based on herpes simplex virus-1 (G47Δ), teserpaturev got conditional and time-limited approval for the treatment of malignant gliomas in Japan. In this review, we summarize the current state of OVT, the synergistic effect of OVT in combination with other immunotherapies as well as the hurdles to successful clinical use. We also provide some suggestions to overcome the challenges in treating of gliomas.

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“…ONYX-015 is an E1B mutant adenovirus that was shown be safe in Phase I study [196]. Another variant AdDelta24-RGD is currently in preclinical and clinical development [197][198][199][200]. Reovirus selectively infects cells with activated Ras pathways and when tested in Phase I study with recurrent glioma demonstrated safety and antiglioma activity [201].…”

Section: Oncolytic Viral Therapymentioning

confidence: 99%

Current State and Future Prospects of Immunotherapy for Glioma

et al. 2018

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There is a large unmet need for effective therapeutic approaches for glioma, the most malignant brain tumor. Clinical and preclinical studies have enormously expanded our knowledge about the molecular aspects of this deadly disease and its interaction with the host immune system. In this review we highlight the wide array of immunotherapeutic interventions that are currently being tested in glioma patients. Given the molecular heterogeneity, tumor immunoediting and the profound immunosuppression that characterize glioma, it has become clear that combinatorial approaches targeting multiple pathways tailored to the genetic signature of the tumor will be required in order to achieve optimal therapeutic efficacy.

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Magnetic Resonance Imaging–Based Assessment of Gadolinium-Conjugated Diethylenetriamine Penta-Acetic Acid Test-Infusion in Detecting Dysfunction of Convection-Enhanced Delivery Catheters

Cited by 11 publications

References 16 publications

Intraputamenal Cerebral Dopamine Neurotrophic Factor in Parkinson's Disease: A Randomized, Double‐Blind, Multicenter Phase 1 Trial

Intraputamenal Cerebral Dopamine Neurotrophic Factor in Parkinson's Disease: A Randomized, Double‐Blind, Multicenter Phase 1 Trial

Oncolytic Viro-Immunotherapy: An Emerging Option in the Treatment of Gliomas

Current State and Future Prospects of Immunotherapy for Glioma

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