The Clinical Core will provide the clinical trial infrastructure to support the clinical trial and related translational research that is generated by the four projects that constitute this SPORE application. The components of the Clinical Core leverage the extensive resources and expertise at MD Anderson in clinical and translational research. As the research efforts proposed in the current application represent extensions and expansions of ongoing efforts, the Clinical Core will continue to provide the support and expertise to develop and manage the highly innovative clinical trials that develop from the proposed research efforts. Additionally, recognizing that the scope of clinical trials may encompass from early stage (proof-of principle) studies examining drug/agent delivery and tissue-based efficacy (i.e. pharmacodynamics) to larger, randomized multicenter clinical trials, we have developed a robust web-based clinical trials management software package, the Data Management Initiative (DMI). This system supports state-of-the art tracking of all critical elements of the clinical trial including patient outcomes, adverse events and drug dosing. It contains internal auditing functions thereby limiting resource consuming queries. Furthermore, the DMI has been approved by the FDA for studies containing IND agents and is also approved for registration clinical trials. The Clinical Core will support the specific SPORE projects as described: Project 1: A Phase l/ll study combining the Delta-24 oncolytic virus with temozolomide. Early phase study of evaluating mesenchymal stem cell mediated delivery of Delta-24 into human glioblastoma. Project 2: A Phase I study of combination signal transduction agents followed by a 2-stage multi-arm Bayesian based Adaptive Selection Design clinical trial to test preclinical developed drug combinations. Project 3: No direct Clinical Core support needed for these clinical-molecular studies using outcomes and molecular profiles from large clinical trials. Project 4: A Phase I clinical trial of WPI 066 an oral STAT3 inhibitor with an arm that will evaluate treatment delivery and impact on molecular targets (pharmacokinetics and pharmacodynamics).

Public Health Relevance

The Clinical Core will provide the clinical trials infrastructure to enable the innovative clinical studies that are developed within each of the SPORE projects to be completed with the highest level of oversight and data quality. The Clinical Core has developed resources to support early stage studies that examine treatment effects on the tumor to large scale multi-center studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Specialized Center (P50)
Project #
5P50CA127001-07
Application #
8753983
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
7
Fiscal Year
2014
Total Cost
Indirect Cost
City
Houston
State
TX
Country
United States
Zip Code
77030
Lu, Sean; Wang, Yugang (2018) Nonmetabolic functions of metabolic enzymes in cancer development. Cancer Commun (Lond) 38:63
Qiao, Yang; Gumin, Joy; MacLellan, Christopher J et al. (2018) Magnetic resonance and photoacoustic imaging of brain tumor mediated by mesenchymal stem cell labeled with multifunctional nanoparticle introduced via carotid artery injection. Nanotechnology 29:165101
Zinn, Pascal O; Singh, Sanjay K; Kotrotsou, Aikaterini et al. (2018) A Coclinical Radiogenomic Validation Study: Conserved Magnetic Resonance Radiomic Appearance of Periostin-Expressing Glioblastoma in Patients and Xenograft Models. Clin Cancer Res 24:6288-6299
Shah, Maitri Y; Ferracin, Manuela; Pileczki, Valentina et al. (2018) Cancer-associated rs6983267 SNP and its accompanying long noncoding RNA CCAT2 induce myeloid malignancies via unique SNP-specific RNA mutations. Genome Res 28:432-447
Mostovenko, Ekaterina; Végvári, Ákos; Rezeli, Melinda et al. (2018) Large Scale Identification of Variant Proteins in Glioma Stem Cells. ACS Chem Neurosci 9:73-79
Chen, Zhihua; Morales, John E; Guerrero, Paola A et al. (2018) PTPN12/PTP-PEST Regulates Phosphorylation-Dependent Ubiquitination and Stability of Focal Adhesion Substrates in Invasive Glioblastoma Cells. Cancer Res 78:3809-3822
Wang, Yugang; Xia, Yan; Lu, Zhimin (2018) Metabolic features of cancer cells. Cancer Commun (Lond) 38:65
Noh, Hyangsoon; Zhao, Qingnan; Yan, Jun et al. (2018) Cell surface vimentin-targeted monoclonal antibody 86C increases sensitivity to temozolomide in glioma stem cells. Cancer Lett 433:176-185
Lee, Jong-Ho; Liu, Rui; Li, Jing et al. (2018) EGFR-Phosphorylated Platelet Isoform of Phosphofructokinase 1 Promotes PI3K Activation. Mol Cell 70:197-210.e7
Lang, Frederick F; Conrad, Charles; Gomez-Manzano, Candelaria et al. (2018) Phase I Study of DNX-2401 (Delta-24-RGD) Oncolytic Adenovirus: Replication and Immunotherapeutic Effects in Recurrent Malignant Glioma. J Clin Oncol 36:1419-1427

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