Children's Oncology Group Pediatric Early Phase Clinical Trial Network
儿童肿瘤学组儿科早期临床试验网络
基本信息
- 批准号:10414481
- 负责人:
- 金额:$ 420.45万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-20 至 2023-07-31
- 项目状态:已结题
- 来源:
- 关键词:AdolescentAdultAdverse eventBiologicalBiological ModelsBiologyCharacteristicsChildChildhoodClinical PharmacologyClinical ResearchClinical TrialsClinical Trials NetworkCohort StudiesCommon Terminology Criteria for Adverse EventsComplexCountryCytotoxic agentDNA Sequence AlterationDataDatabasesDevelopmentDoseDrug KineticsEnrollmentEnsureEvaluationFoundationsGenesGenomicsImageInformaticsInfrastructureInstitutionInternationalLaboratory ResearchLaboratory StudyLeadMalignant Childhood NeoplasmMalignant NeoplasmsMissionModelingMolecular ProfilingMolecular TargetNew AgentsOutcomeParentsPathway interactionsPatient Outcomes AssessmentsPatientsPediatric NeoplasmPediatric OncologyPediatric Oncology GroupPeer ReviewPharmacogeneticsPharmacologyPharmacology StudyPhasePilot ProjectsProcessProxyReportingResourcesSignal TransductionSiteSymptomsSystemTherapeuticToxic effectanti-cancer therapeuticantitumor effectbasecancer therapycohortdrug actiondrug dispositionearly phase clinical trialearly phase trialexome sequencingimaging modalityimaging studyimprovednovelnovel anticancer drugpatient populationphase 3 testingpre-clinicalresponsetargeted agenttargeted treatmenttranscriptome sequencingtreatment strategytumortumor DNA
项目摘要
The mission of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to identify and
develop effective new agents for children and adolescents with cancer, through rational and
efficient clinical and laboratory research. PEP-CTN clinical trials will incorporate correlative
genomics, biology, pharmacology, and imaging studies to further the understanding of the
disposition and action of new agents introduced into the treatment of children with cancer.
Annually, the PEP-CTN will enroll approximately 120 children and adolescents with cancer onto
clinical trials of novel anticancer agents at the 21 core premier pediatric oncology sites throughout
the country. The network institutions are selected through a peer review process, and serve as
a national and international model for new agent development in pediatric oncology. The PEP-
CTN will leverage the database infrastructure and resources of the parent Children's Oncology
Group while maintaining its own administrative and operational infrastructure to ensure rapid
development, implementation, and reporting of specialized and complex early phase clinical trials.
The PEP-CTN has expertise and resources for the conduct of translational biology,
pharmacokinetic, and pharmacogenetic studies, and utilizes state-of-the-art informatics systems
to facilitate the transfer of response and correlative imaging studies for central review and
analyses.
The PEP-CTN's primary specific aims are: 1) To safely and efficiently introduce novel anticancer
agents into the pediatric setting through the conduct of early phase clinical trials; 2) To
expeditiously obtain preliminary efficacy signals through use of phase 2 expansion cohorts and
pilot studies in order to inform tumor specific trials that will be conducted across COG sites; 3) To
perform genomic analyses, including single gene studies or gene panels, to identify appropriate
patients for early phase studies of targeted agents; 4) To identify associations of tumor
characteristics with response to new agents using genomic analyses such as whole exome
sequencing and RNA sequencing; 5) To incorporate pharmacologic and biologic endpoints,
including circulating tumor DNA, other translational laboratory studies, and imaging modalities,
into early phase studies, in order to enhance our understanding of the new agents and their effect
on tumors.. Development of targeted therapy for childhood cancer is a high priority as it offers the
prospect of more efficacious and less toxic therapeutics.
儿科早期临床试验网络(PEP-CTN)的任务是确定和
为患有癌症的儿童和青少年开发有效的新药物,通过合理和
高效的临床和实验室研究。PEP-CTN临床试验将纳入相关
基因组学、生物学、药理学和成像研究,以加深对
儿童癌症治疗中引入的新药物的处置和作用。
每年,PEP-CTN将招收大约120名癌症儿童和青少年参加
新型抗癌药物在21个主要儿科肿瘤学核心站点的临床试验
这个国家。这些网络机构是通过同行审查程序选出的,并作为
儿科肿瘤学新药开发的国内和国际模式。PEP-
CTN将利用家长儿童肿瘤学的数据库基础设施和资源
同时维护自己的行政和运营基础设施,以确保快速
专门和复杂的早期临床试验的开发、实施和报告。
PEP-CTN拥有进行转译生物学的专业知识和资源,
药代动力学和药物遗传学研究,并利用最先进的信息学系统
促进反应和相关影像研究的转移,以供中央审查和
分析。
PEP-CTN的主要具体目标是:1)安全有效地引入新型抗癌药物
通过进行早期临床试验将药物引入儿科环境;2)
通过使用二期扩展队列快速获得初步疗效信号
先导性研究,以告知将在COG地点进行的肿瘤特异性试验;3)
进行基因组分析,包括单基因研究或基因小组,以确定合适的
患者进行靶向药物的早期研究;4)确定肿瘤的相关性
利用全外显子组等基因组分析方法对新制剂的反应特性
测序和RNA测序;5)结合药理学和生物学终点,
包括循环肿瘤DNA,其他翻译实验室研究,以及成像方式,
进入早期研究阶段,以加强我们对新制剂及其效果的了解
在肿瘤上..开发针对儿童癌症的靶向治疗是一个高度优先的问题,因为它提供了
更有效、毒性更低的治疗方法的前景。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Brenda J. Weigel其他文献
Safety and Activity of Flotetuzumab in Pediatric and Young Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia: Results from the COG PEPN1812 Phase 1 Trial
- DOI:
10.1182/blood-2022-158029 - 发表时间:
2022-11-15 - 期刊:
- 影响因子:
- 作者:
Adam J. Lamble;Xiaowei Liu;Charles Minard;Olga Militano;Melanie Brooke Bernhardt;Todd M. Cooper;Edward A. Kolb;Erin H. Breese;Elizabeth Fox;Sarah K Tasian;Brenda J. Weigel - 通讯作者:
Brenda J. Weigel
PEPN2312: A Pediatric Early Phase Clinical Trials Network (PEP-CTN) Phase 1 Trial of Imetelstat with Fludarabine/Cytarabine in Pediatric Patients with Relapsed/Refractory AML, MDS, or JMML
- DOI:
10.1182/blood-2024-207907 - 发表时间:
2024-11-05 - 期刊:
- 影响因子:
- 作者:
Alexandra McLean Stevens;Maureen M. O'Brien;Xiaowei Liu;Charles G Minard;Olga Militano;Joel M Reid;Shyamala Navada;Todd M Cooper;Sarah K. Tasian;Elizabeth Fox;Brenda J. Weigel - 通讯作者:
Brenda J. Weigel
Brenda J. Weigel的其他文献
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{{ truncateString('Brenda J. Weigel', 18)}}的其他基金
Children's Oncology Group Pediatric Early Phase Clinical Trial Network
儿童肿瘤学组儿科早期临床试验网络
- 批准号:
9789854 - 财政年份:2018
- 资助金额:
$ 420.45万 - 项目类别:
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