scholarly journals EPCT-08. TRIAL WORKING GROUPS FOR PAEDIATRIC BRAIN TUMOURS

2021 ◽  
Vol 23 (Supplement_1) ◽  
pp. i48-i48
Author(s):  
Ruman Rahman ◽  
David Walker ◽  
Emma Campbell ◽  
Kristian Aquilina
Keyword(s):  
Drug Delivery ◽  
Clinical Trials ◽  
Brain Tumour ◽  
Brain Tumours ◽  
International Workshop ◽  
Convection Enhanced Delivery ◽  
Children With Cancer ◽  
Cns Drug Delivery ◽  
Working Groups ◽  
Paediatric Brain Tumours

Abstract Introduction Brain tumours are the biggest cancer killer in children and young adults. Several recent developments have the potential to change the treatment of brain tumours in children. These include ultrasound-mediated blood-brain barrier disruption, convection enhanced delivery, polymer delivery systems and electric field therapy, as well as intra-arterial, intra-CSF and intra-nasal chemotherapy. To date, there have been very few clinical trials to evaluate any of these. The science and technology underlying these developments is not traditionally embedded within the standard paediatric neuro-oncology network. In addition, custom-built hardware, novel surgical procedures and, in some cases, the testing and licensing of implantable devices, add difficulty at the regulatory level. Methods The authors participated in an international workshop funded by the charity Children with Cancer UK in 2016, where different experimental techniques aimed at optimising CNS drug delivery were discussed. Following this workshop and two subsequent workshops run by the CBTDDC (Children’s Brain Tumour Drug Delivery Consortium) in 2018 and 2020, the CBTDDC and the recently developed ITCC (Innovative Therapies for Children with Cancer) brain tumour group started working together to set up a new initiative. This aims to develop CNS-delivery-focused trial working groups for paediatric brain tumours. Results We have assembled a prestigious steering group, comprising international researchers and clinicians with expertise in diverse aspects of translational and clinical research in CNS drug delivery. At our first group meeting in March, participants will discuss the most effective ways of translating the emerging drug delivery modalities into clinical trials. Prioritised actions will be taken forward and the group will reconvene to discuss developments and next steps at a workshop in the Autumn. Conclusion We present this abstract to the SNO Paediatric conference to raise awareness of this initiative with the large number of relevant stakeholders who will be attending the event.

scholarly journals CLRM-08. TRIAL WORKING GROUPS FOR PAEDIATRIC BRAIN TUMOURS

2021 ◽  
Vol 3 (Supplement_4) ◽  
pp. iv2-iv3
Author(s):  
Ruman Rahman ◽  
David Walker ◽  
Emma Campbell ◽  
Kristian Aquilina
Keyword(s):  
Drug Delivery ◽  
Clinical Trials ◽  
Brain Tumour ◽  
Brain Tumours ◽  
International Workshop ◽  
Convection Enhanced Delivery ◽  
Children With Cancer ◽  
Street Hospital ◽  
Oncology Research ◽  
Paediatric Brain Tumours

Abstract INTRODUCTION Brain tumours are the biggest cancer killer in children and young adults. Several recent developments have the potential to change the outlook for these children, including intra-CSF chemotherapy, ultrasound-mediated blood-brain barrier disruption, convection enhanced delivery, polymer delivery systems, electric field therapy, and intra-arterial and intra-nasal chemotherapy. To date, there have been very few clinical trials to evaluate these. In addition, custom-built hardware, novel surgical procedures and the testing and licensing of implantable devices add difficulty at the regulatory level. METHODS The authors participated in an international workshop funded by the charity Children with Cancer UK in 2016, where different experimental techniques aimed at optimising CNS drug delivery were discussed. Following this and two subsequent workshops run by the CBTDDC (Children’s Brain Tumour Drug Delivery Consortium), the CBTDDC and the ITCC (Innovative Therapies for Children with Cancer) brain tumour group launched the ‘Clinical Trials Working Group for Central Nervous System Drug Delivery’. This aims to accelerate clinical trials to assess the safety and effectiveness of drug delivery devices for the treatment of paediatric brain tumours. RESULTS On 1 March, 2021, CBTDDC and Mr Kristian Aquilina (Consultant Paediatric Neurosurgeon at Great Ormond Street Hospital) hosted the first steering group meeting, comprising 38 leading brain tumour research scientists and clinicians from the UK, EU and US. CONCLUSION The ideas generated during the March meeting are driving the agenda for a Clinical Trials Workshop that will be held in the autumn of 2021. In particular, there was agreed consensus that a ‘Roadmap’ document for pre-clinical to clinical translation needs to be created and shared with the paediatric neuro-oncology research community. We present this abstract to the CNS Clinical Trials Meeting to raise awareness of this initiative with the large number of relevant stakeholders who will be attending the event.

scholarly journals Trial working groups for paediatric brain tumours

2021 ◽  
Vol 23 (Supplement_4) ◽  
pp. iv9-iv9
Author(s):  
Kristian Aquilina ◽  
Ruman Rahman ◽  
David Walker ◽  
Emma Campbell
Keyword(s):  
Drug Delivery ◽  
Clinical Trials ◽  
Brain Tumour ◽  
Brain Tumours ◽  
Delivery Systems ◽  
Children With Cancer ◽  
Cns Drug Delivery ◽  
Oncology Research ◽  
Steering Group ◽  
Paediatric Brain Tumours

Abstract Aims Children's brain tumours are the biggest cancer killer in children and young adults. Several recent developments have the potential to change the treatment of brain tumours in children. These include intra-CSF chemotherapy, ultrasound-mediated blood-brain barrier disruption, convection enhanced delivery, polymer delivery systems and electric field therapy, as well as intra-arterial and intra-nasal chemotherapy. To date, there have been very few clinical trials to evaluate any of these. The science and technology underlying these developments is not traditionally embedded within the standard paediatric neuro-oncology network. In addition, custom-built hardware, novel surgical procedures and, in some cases, the testing and licensing of implantable devices, add difficulty at the regulatory level. Method The authors participated in an international workshop funded by the charity Children with Cancer UK in 2016, where different experimental techniques aimed at optimising CNS drug delivery were discussed. Following this workshop and two subsequent workshops run by the CBTDDC (Children’s Brain Tumour Drug Delivery Consortium) in 2018 and 2020, the CBTDDC and the recently developed ITCC (Innovative Therapies for Children with Cancer) brain tumour group started working together to set up a new initiative. Called the ‘Clinical Trials Working Group for Central Nervous System Drug Delivery’, this aims to accelerate clinical trials to assess the safety and effectiveness of drug delivery devices for the treatment of paediatric brain tumours. On March 1st, 2021, CBTDDC with guest chair, Mr Kristian Aquilina (Consultant Paediatric Neurosurgeon at Great Ormond Street Hospital), hosted the first virtual meeting of this group. Results We have assembled a prestigious steering group, comprising international researchers and clinicians with expertise in diverse aspects of translational and clinical research in CNS drug delivery. At our first group meeting on March 1st, 2021, 38 leading brain tumour research scientists and clinicians from the UK, EU and US tackled the challenges head-on, with commitment and a driving passion to identify and move forwards with the most effective ways of translating drug delivery modalities into clinical trials. Attendees were split into three break-out sessions based on distinct drug delivery systems, and lots of insightful comments were collated. Conclusion The ideas generated during the 1st March meeting will help form the basis of a CBTDDC ‘Clinical Trials’ workshop in the autumn of 2021. In particular, there was an agreed consensus that a key objective will be the creation of a ‘Roadmap’ document for pre-clinical to clinical translation which would be shared with the paediatric neuro-oncology research community. CBTDDC look forward to working with steering group as we act on their recommendations to address the current challenges faced by translational drug delivery research. We present this abstract to the BNOS Annual 2021 Meeting to raise awareness of this initiative with the large number of relevant stakeholders who will be attending the event.

EXTH-79. TRIAL WORKING GROUPS TO EXPEDITE PRECLINICAL TRANSLATION FOR PAEDIATRIC BRAIN TUMOURS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi181-vi181
Author(s):  
Ruman Rahman ◽  
David Walker ◽  
Emma Campbell ◽  
Kristian Aquilina
Keyword(s):  
Drug Delivery ◽  
Clinical Trials ◽  
Brain Tumours ◽  
Scale Up ◽  
Convection Enhanced Delivery ◽  
Prototype Development ◽  
Blood Brain Barrier Disruption ◽  
The Uk ◽  
Survey Responses ◽  
Paediatric Brain Tumours

Abstract INTRODUCTION Children's brain tumours are the biggest cancer killer in children and young adults. Several recent developments have the potential to change the treatment of brain tumours in children, including intra-CSF chemotherapy, ultrasound-mediated blood-brain barrier disruption, convection enhanced delivery, polymer delivery systems and electric field therapy, as well as intra-arterial and intra-nasal chemotherapy. To date, there have been very few clinical trials to evaluate these. The science and technology underlying these developments is not traditionally embedded within the paediatric neuro-oncology network. In addition, custom-built hardware, novel surgical procedures, and the testing and licensing of implantable devices, add difficulty at the regulatory level. METHODS In early 2021, we launched the ‘Clinical Trials Working Group for Central Nervous System Drug Delivery’. This aims to accelerate clinical trials to assess the safety and effectiveness of drug delivery devices for treating paediatric brain tumours. On March 1st, we hosted the first virtual meeting of this group, involving 38 leading brain tumour scientists and clinicians from the UK, EU and US. RESULTS A pre-meeting survey identified the main challenges to acceleration of this preclinical to clinical research pathway as: (1) a lack of specific funding for prototype development and/or scale up for clinical trials; (2) difficulties in navigation of the regulatory landscape; (3) lack of accurate preclinical models; and (4) increased need for multicentric working. Discussion at the meeting echoed the survey responses, and there was agreed consensus that a ‘Roadmap’ document for preclinical to clinical translation should be created. Following the meeting, we launched a pump prime funding call for projects that will address challenges along the preclinical to clinical pathway to move trial proposals into an ‘advanced state of readiness’. CONCLUSION The ideas generated during the initial meeting will help form the basis of a ‘Clinical Trials’ workshop in the autumn of 2021.

scholarly journals Highlights of Children with Cancer UK’s Workshop on Drug Delivery in Paediatric Brain Tumours

2016 ◽  
Vol 10 ◽  
Author(s):  
Audrey Nailor ◽  
David A Walker ◽  
Thomas S Jacques ◽  
Kathy E Warren ◽  
Henry Brem ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Brain Tumours ◽  
Children With Cancer ◽  
Paediatric Brain Tumours

scholarly journals Convection-enhanced delivery to the central nervous system

2015 ◽  
Vol 122 (3) ◽  
pp. 697-706 ◽  
Author(s):  
Russell R. Lonser ◽  
Malisa Sarntinoranont ◽  
Paul F. Morrison ◽  
Edward H. Oldfield
Keyword(s):  
Drug Delivery ◽  
Central Nervous System ◽  
Clinical Trials ◽  
Nervous System ◽  
Convective Flow ◽  
Clinical Applications ◽  
Systemic Delivery ◽  
Convection Enhanced Delivery ◽  
The Central Nervous System ◽  
Real Time Tracking

Convection-enhanced delivery (CED) is a bulk flow–driven process. Its properties permit direct, homogeneous, targeted perfusion of CNS regions with putative therapeutics while bypassing the blood-brain barrier. Development of surrogate imaging tracers that are co-infused during drug delivery now permit accurate, noninvasive real-time tracking of convective infusate flow in nervous system tissues. The potential advantages of CED in the CNS over other currently available drug delivery techniques, including systemic delivery, intrathecal and/or intraventricular distribution, and polymer implantation, have led to its application in research studies and clinical trials. The authors review the biophysical principles of convective flow and the technology, properties, and clinical applications of convective delivery in the CNS.

scholarly journals Using surgical and oncology workload to plan brain tumour trial recruitment in England

2019 ◽  
Vol 21 (Supplement_4) ◽  
pp. iv11-iv12
Author(s):  
Kerlann Le Calvez ◽  
Peter Treasure ◽  
Matt Williams
Keyword(s):  
Clinical Trials ◽  
Brain Tumour ◽  
Brain Tumours ◽  
Adult Patients ◽  
Trial Recruitment ◽  
Trade Off ◽  
Primary Brain Tumour ◽  
Rational Planning ◽  
The Brain ◽  
Over Time

Abstract Introduction Access to clinical trials is a common request for patients with brain tumours. However, opening clinical trials requires additional work per centre opened. We have previously shown that surgical and oncology workload varies between centres, and fluctuates over time. There is a trade-off between offering access to clinical trials and increasing costs associated with opening trials in centres that treat few patients. Methods We used two separate datasets from England covering 3 years – one for neurosurgical workload and one for radiotherapy. We only included adult patients and calculated cumulative proportions of the malignant primary brain tumour population (C71) by number of centres. We investigated stability by checking how many patients would have to be added/ removed from a centre to change their rank. Results There were 7061 surgical and 5060 radiotherapy patients. To capture 25% of patients, we would need to open trials in 4 surgical/5 radiotherapy centres; for 50%, 9 surgical/ 13 radiotherapy centres; for 75%, 16 surgical/ 24 radiotherapy centres. Centre rank was fluid: adding 16 surgical/9 radiotherapy patients would change the rank of a centre. Discussion These are the first data to allow for rational planning of trials in brain tumour patients. We have shown that we can reach 75% of the brain tumour population by opening trials in ~50% of surgical and radiotherapy centres. Centre rank alters over year, so we should be cautious about being too prescriptive. Nonetheless, these data should allow some rational planning of trial centre inclusion.

Paediatric brain tumours

2019 ◽  
pp. 1009-1022
Author(s):  
Jonathan Roth ◽  
Shlomi Constantini
Keyword(s):  
Brain Tumour ◽  
Blood Volume ◽  
Brain Tumours ◽  
Genetic Factors ◽  
Adult Population ◽  
Adult Brain ◽  
Related Factors ◽  
The Subject ◽  
Surgical Aspects ◽  
Paediatric Brain Tumours

Paediatric brain tumours (PBT) are a unique entity, in children and in the overall general brain tumour population. They are distinct from adult brain tumours for several reasons, including patient-related factors (size, blood volume), location of the tumours, histological and genetic factors, treatment factors, and prognosis. Even technical surgical aspects may differ from those applied in the adult population. This chapter reviews the main aspects of PBT and their treatment in relation to the aforementioned factors. This text has pinpointed the most important topics of PBT but due to the breadth of the subject, this text cannot be a comprehensive account of every aspect of these pathologies or their treatments.

scholarly journals SCIDOT-08. CHILDREN’S BRAIN TUMOUR DRUG DELIVERY CONSORTIUM (CBTDDC)

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi274-vi274
Author(s):  
Ruman Rahman ◽  
Emma Campbell ◽  
Henry Brem ◽  
Monica Pearl ◽  
Jordan Green ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Brain Tumour ◽  
Research Database ◽  
Policy Makers ◽  
Cns Drug Delivery ◽  
Research Collaborations ◽  
The Us ◽  
Delivery Platform ◽  
The Uk ◽  
The Brain

Abstract INTRODUCTION The brain tumour community has seen significant progress in the discovery of new therapeutic targets and anticancer drugs. Unfortunately, advances in how to deliver drugs to the brain lag behind. The blood-brain barrier restricts the entry of many small-molecule drugs and nearly all large molecule drugs that have been developed to treat brain disorders. METHODS Following an international CNS drug delivery workshop in 2016, we were awarded funding from Children with Cancer UK to launch the Children’s Brain Tumour Drug Delivery Consortium (CBTDDC; www.cbtddc.org; @cbtddc). RESULTS The CBTDDC launched in 2017 (in Europe and the US) to raise awareness of the challenge of drug delivery in childhood brain tumours, and to initiate and strengthen research collaborations to accelerate the development of drug delivery systems. We ran a Workshop on Drug Delivery to the Brain, attracting 52 delegates from the UK, Belgium, Spain and Portugal. We liaised with UK-based funders over the drug delivery agenda, and with UK policy makers. In the US, we jointly organised the SIGN2019 meeting and we are currently liaising with the leads of Project ‘All In’ DIPG about how we can lend our support to this project. As of June 2019, 150 individuals have registered with the consortium, representing researchers, clinicians, charities, patient groups and industry. These stakeholders represent 70 research institutions, covering 15 countries (France, UK, Italy, Sweden, The Netherlands, USA, Greece, Germany, Belgium, Cuba, Denmark, Spain, Portugal, Israel and Egypt). We host a freely accessible online collaborative research database, containing the details of over 70 researchers. CONCLUSION We believe that collaboration between clinicians and multi-disciplinary researchers is vital to solving the brain tumour drug delivery challenge. We hope to raise awareness of the CBTDDC, and to extend our invitation for collaborators to join the consortium, through SCIDOT’s unrivalled drug delivery platform.

scholarly journals Maternal cured meat consumption during pregnancy and risk of paediatric brain tumour in offspring: potentially harmful levels of intake

2001 ◽  
Vol 4 (2) ◽  
pp. 183-189 ◽  
Author(s):  
Janice M Pogoda ◽  
Susan Preston-Martin
Keyword(s):  
Literature Review ◽  
Brain Tumour ◽  
Brain Tumours ◽  
Meat Consumption ◽  
Cured Meats ◽  
Cured Meat ◽  
Survey Results ◽  
Paediatric Brain Tumour ◽  
Paediatric Brain Tumours ◽  
Nitrite Content

AbstractObjectiveTo describe the relationship between specific levels of nitrite intake from cured meat consumption during pregnancy and the relative risk of paediatric brain tumours in the offspring.DesignExposure data were previously collected for a population-based case–control study of paediatric brain tumours; data on nitrite content were obtained by a comprehensive literature review of surveys of residual nitrite content in cured meats published in the USA and Canada. The level of nitrite intake for each mother was predicted by year of pregnancy based on survey results. Dose–response was evaluated both categorically and continuously using polynomial and quadratic spline regression.SettingThe US west coast: Los Angeles County, the San Francisco–Oakland Bay Area and the Seattle–Puget Sound area.SubjectsThere were 540 cases diagnosed between 1984 and 1990 at ages varying from 0 to 19 years, and 801 controls frequency-matched by geographic area, age and birth year.ResultsIn general, survey results suggest a trend of decreasing nitrite levels in cured meats over time. We observed a moderate increase in brain tumour risk in the offspring of mothers with relatively low levels of nitrite consumption from cured meats during pregnancy, and a two- to three-fold risk increase in offspring of mothers who consumed 3 mg day−1 nitrite from cured meats (about 125 g day−1 of cured meat consumption throughout the pregnancy).ConclusionsA substantial risk of paediatric brain tumour appears to be associated with relatively high levels of maternal cured meat consumption during pregnancy. A more scientifically valid approach than a literature review to estimate nitrite intake from cured meats and data from a large group of highly exposed subjects would be useful in determining potentially harmful levels.

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