This core provides all projects with centralized clinical trial support and provides the infrastructure of personnel and services essential to safely and effectively support such research. Core services will be provided in regulatory affairs, study co-ordination, quality assurance and control and data safety monitoring. The Regulatory affairs component collaborates with investigators to develop and submit all required regulatory documents, including initial and revised submissions to the IRB, IBC, FDA and NIH/ORDA and the subsequent annual reports. This core has extensive experience with IND submissions, successfully submitting 48 studies of complex biologies, under 27 INDs during the past 10 years;the 20 completed studies have enrolled over 400 patients. The core arranges group meetings of investigators, attending physicians, research nurse, data managers, to provide training on the SOPs for each protocol and provides research nurse support to ensure that clinical studies are conducted safely, accurately and efficiently The Quality Control (QC) program will ensure that the standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are followed. The QA program will audit each study after the first patient is enrolled;subsequent audits are held in a randomized way to ensure that studies follow Good Clinical Practices. The core will also co-ordinate data mohitoring with the SPORE Data Review Committee which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies. . Finally, the core accessions follow up samples from patients on clinical trials and enter details into a database in the Good Laboratory Practice (GLP) Laboratory, allowing subsequent follow up testing including flow cytometry in a CLIA certified laboratory.

Public Health Relevance

This core supports the SPORE clinical research studies to ensure they are conducted safely, accijrately and in accordance with applicable regulations. The Core also monitors study outcomes and processes and logs follow up samples allowing evaluation of study outcomes.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Specialized Center (P50)
Project #
2P50CA126752-06
Application #
8339664
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
6
Fiscal Year
2012
Total Cost
$153,159
Indirect Cost
$72,324
Name
Baylor College of Medicine
Department
Type
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
Iwahori, Kota; Kakarla, Sunitha; Velasquez, Mireya P et al. (2015) Engager T cells: a new class of antigen-specific T cells that redirect bystander T cells. Mol Ther 23:171-8
Ngo, Minhtran Charlotte; Ando, Jun; Leen, Ann M et al. (2014) Complementation of antigen-presenting cells to generate T lymphocytes with broad target specificity. J Immunother 37:193-203
Ok, Chi Young; Li, Ling; Xu-Monette, Zijun Y et al. (2014) Prevalence and clinical implications of epstein-barr virus infection in de novo diffuse large B-cell lymphoma in Western countries. Clin Cancer Res 20:2338-49
Bollard, Catherine M; Gottschalk, Stephen; Torrano, Vicky et al. (2014) Sustained complete responses in patients with lymphoma receiving autologous cytotoxic T lymphocytes targeting Epstein-Barr virus latent membrane proteins. J Clin Oncol 32:798-808
Rouce, Rayne H; Louis, Chrystal U; Heslop, Helen E (2014) Epstein-Barr virus lymphoproliferative disease after hematopoietic stem cell transplant. Curr Opin Hematol 21:476-81
Leen, Ann M; Heslop, Helen E; Brenner, Malcolm K (2014) Antiviral T-cell therapy. Immunol Rev 258:12-29
Xu, Xin; Hegazy, Wael A H; Guo, Linjie et al. (2014) Effective cancer vaccine platform based on attenuated salmonella and a type III secretion system. Cancer Res 74:6260-70
Zhou, Xiaoou; Di Stasi, Antonio; Tey, Siok-Keen et al. (2014) Long-term outcome after haploidentical stem cell transplant and infusion of T cells expressing the inducible caspase 9 safety transgene. Blood 123:3895-905
Papadopoulou, Anastasia; Krance, Robert A; Allen, Carl E et al. (2014) Systemic inflammatory response syndrome after administration of unmodified T lymphocytes. Mol Ther 22:1134-8
Anurathapan, Usanarat; Leen, Ann M; Brenner, Malcolm K et al. (2014) Engineered T cells for cancer treatment. Cytotherapy 16:713-33

Showing the most recent 10 out of 121 publications