The Johns Hopkins Translational Science Team (JH-TST) for the NCI Experimental Therapeutics Clinical Trials Network (ET-CTN) will evaluate promising new therapies for patients with malignant disease in a clinically efficient, regulatory compliant and scientifically rigorous collaborative research environment. The molecular characterization of all enrolled patients will be standard. Building upon a strong foundation in th conduct of early phase trials, we have assembled an interactive and interdisciplinary Team from a pool of investigators involved in SPORE, R01, P01, and U01 projects. Our JH-TST has six aims:
Aim1 -To contribute collaboratively and actively in the ET-CTN as a team member.;
Aim 2 -To conduct informative Phase l/lI clinical trials of novel anti-cancer agents in a timely manner.;
Aim 3 -To collaborate with ET-CTN teams to perform detailed molecular characterization of novel anti-cancer agents and explore pharmacokinetic (PK) - pharmacodynamic (imaging and biomarkers) and pharmacogenomic relationships between relevant indices of drug exposure and clinical, toxicological, and biological endpoints.;
Aim 4 -To implement correlative and biological laboratory studies in """"""""proof of drug mechanism"""""""" early phase studies in order to enhance our understanding of determinants of toxicity and response that, combined with assessment of PK relationships, will be used to select drug dose and schedule for further evaluation.;
Aim 5 -To maintain a clinical trial infrastructure that is current and compliant with regulatory standards that assure quality care to patients enrolled on early phase clinical trials a well as provide prompt data sharing with other investigators and interested parties.;and.
Aim 6 -To train the next generation of investigators in drug development. Through these aims and with a focus on team science and collaboration across UM1 participants, the JH-TST is committed to the success of the ET-CTN. Our Team has averaged 120 patients/year on NCI UOl supported trials. We anticipate that we will easily meet the required 50 patients/year accrual. We will support the Early Phase CIRB and adhere to other metrics of the Operational Efficiency Working Group to assure timely activation, completion, and dissemination of our findings.
Our Team will continue its long-standing contribution to the drug development efforts of the NCI through UM1-based project teams. We anticipate that our contribution within the Network will impact the clinical care of cancer patients. We anticipate enhanced interactions with the National Clinical Trials Network (NCTN) through our ECOG-ACRIN affiliation to bring forward successes from the efforts of the ET-CTN.
|Pratz, Keith W; Koh, Brian D; Patel, Anand G et al. (2016) Poly (ADP-Ribose) Polymerase Inhibitor Hypersensitivity in Aggressive Myeloproliferative Neoplasms. Clin Cancer Res 22:3894-902|
|Rudek, Michelle A; Graham, Richard A; Ratain, Mark J (2016) Harmonization of Renal Function Assessment Is Needed During Early Clinical Development of Oncology Drugs. J Clin Oncol 34:103-4|
|Yun, Seongseok; Vincelette, Nicole D; Knorr, Katherine L B et al. (2016) 4EBP1/c-MYC/PUMA and NF-ÎºB/EGR1/BIM pathways underlie cytotoxicity of mTOR dual inhibitors in malignant lymphoid cells. Blood 127:2711-22|
|Mansfield, Aaron S; Rudek, Michelle A; Vulih, Diana et al. (2016) The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects. Clin Cancer Res :|
|Gojo, Ivana; Beumer, Jan H; Pratz, Keith W et al. (2016) A phase 1 study of the PARP inhibitor veliparib in combination with temozolomide in acute myeloid leukemia. Clin Cancer Res :|
|Zeidner, Joshua F; Zahurak, Marianna; Rosner, Gary L et al. (2015) The evolution of treatment strategies for patients with chronic myeloid leukemia relapsing after allogeneic bone marrow transplant: can tyrosine kinase inhibitors replace donor lymphocyte infusions? Leuk Lymphoma 56:128-34|
|Knaus, Hanna A; Kanakry, Christopher G; Luznik, Leo et al. (2015) Immunomodulatory drugs II: Immune Checkpoint Agents in Acute Leukemia. Curr Drug Targets :|
|Haley, Lisa; Tseng, Li-Hui; Zheng, Gang et al. (2015) Performance characteristics of next-generation sequencing in clinical mutation detection of colorectal cancers. Mod Pathol 28:1390-9|
|Seymour, Lesley; Groshen, Susan; Rosner, Gary L et al. (2015) Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. Clin Cancer Res 21:5057-63|
|Lin, Ming-Tseh; Tseng, Li-Hui; Dudley, Jonathan C et al. (2015) A Novel Tandem Duplication Assay to Detect Minimal Residual Disease in FLT3/ITD AML. Mol Diagn Ther 19:409-17|
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