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Vanderbilt Phase I Translational Research Program

范德比尔特第一阶段转化研究计划

基本信息

批准号：
7198161
负责人：
MACE L ROTHENBERG
金额：
$ 10万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-03-14 至 2009-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7198161
关键词：
ABCB1 gene Academic Medical Centers African American Am 80 Anticonvulsants Antineoplastic Agents Area Award Basic Science Berlin Biochemical Biology Cancer Center Cancer Therapy Evaluation Program Cells Clinical Clinical Investigator Clinical Pharmacists Clinical Pharmacology Clinical Research Clinical Trials Collaborations Colon Carcinoma Complement Comprehensive Cancer Center Data Development Direct Costs Dose Drug Interactions Drug Kinetics Enrollment Epidermal Growth Factor Receptor Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Felis catus Funding Gelatinase A Genes Genetic Polymorphism Goals Grant Growth High Pressure Liquid Chromatography Image Individual Information Specialists Invasive Irinotecan/Paclitaxel Jordan Laboratories Lung Malignant Neoplasms Medical Medical center Metabolism Methodology Methods Molecular Molecular Target Myristica fragrans Neoadjuvant Therapy New Agents Numbers Nursing Research PTGS2 gene Patients Peripheral Personal Satisfaction Pharmaceutical Preparations Pharmacodynamics Pharmacogenetics Pharmacology Phase Phase I Clinical Trials Phosphorylation Physicians Play Principal Investigator Program Research Project Grants Proteasome Inhibition Qualifying Radiation Range Rectal Cancer Reproduction spores Research Research Design Research Infrastructure Research Personnel Resources Role Scientist Signal Transduction Pathway Specialist Specimen Staging TNF gene Testing Toxic effect Training Translational Research Transmembrane Transport Tumor Necrosis Factor-alpha U-Series Cooperative Agreements Underserved Population United States Work Writing base college design drug development drug mechanism drug metabolism experience improved in vivo inhibitor/antagonist innovation insight interest irinotecan liquid chromatography mass spectrometry multicatalytic endopeptidase complex novel progesterone 11-hemisuccinate-(2-iodohistamine)programs protocol development quality assurance research study response skills success

项目摘要

This proposal describes a combined effort of the Vanderbilt-Ingram Comprehensive Cancer Center (VICCC), the Vanderbilt University Medical Center (VUMC) and, eventually, the Meharry Medical Center (MMC), to expand ongoing efforts in Phase I clinical research and establish a Phase I Translational Research Program. The goals of this proposal are to conduct early phase, dose-ranging trials of new anticancer agents to characterize their toxicity and pharmacology as well as to explore their effects on molecular targets to provide new scientific insights into drug mechanisms of action and determinants of response. The Program brings together clinical investigators experienced in early phase clinical trials with basic scientists at Vanderbilt who are studying the biology of molecules, such as EGFR and COX-2, that are the focus of some of the most promising molecularly-targeted therapies. Working together, these researchers have taken advantage of complementary skills and interests to design and initiate innovative translational research studies. Pharmacokinetic analysis of novel compounds will be performed using highly sensitive and specific methods of drug quantitation including HPLC, LC/MS, and GC/MS methodology. The excellent resources available at VICCC and VUMC will promote the expansion of pharmacogenetic analyses in early phase clinical trials of novel agents using hypothesis-testing as well as hypothesis-generating approaches. Pharmacodynamic relationships will be explored using PK as well as PG data. Data is presented that highlight recent accomplishments of the Phase ! effort at Vanderbilt and establish the adequacy of patient resources needed to carry out 2-3 translational research studies per year under this cooperative agreement. Over the past 4 years there has been a 63% increase in the number of studies open, a 38% increase in the number of patients enrolled, more than a doubling of the number of physicians entering patients into Phase I studies, and a doubling of the number of physicians writing and chairing Phase t trials. Data is also presented demonstrating the regional impact of Vanderbilrs Phase I program in the Southeast United States, an area currently without an NCI-designated Phase I center. We describe our plan for the graduated involvement of MMC in this cooperative agreement that will enhance both the access of African-American patients to Phase I clinical trials and the involvement of clinical and basic researchers from Meharry in the design and conduct of these early phase translational research studies. In summary, we believe that the support from this cooperative agreement will significantly enhance our efforts to understand the clinical, pharmacologic, and molecular impact of important new anficancer agents and optimize their further development and utilization.

该提案描述了范德比尔特-英格拉姆综合癌症中心（VICCC）的联合努力