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.
|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|
|Wilky, B A; Rudek, M A; Ahmed, S et al. (2015) A phase I trial of vertical inhibition of IGF signalling using cixutumumab, an anti-IGF-1R antibody, and selumetinib, an MEK 1/2 inhibitor, in advanced solid tumours. Br J Cancer 112:24-31|
|Reiss, Kim A; Herman, Joseph M; Zahurak, Marianna et al. (2015) A Phase I study of veliparib (ABT-888) in combination with low-dose fractionated whole abdominal radiation therapy in patients with advanced solid malignancies and peritoneal carcinomatosis. Clin Cancer Res 21:68-76|
|Gojo, Ivana; Karp, Judith E (2014) New strategies in acute myelogenous leukemia: leukemogenesis and personalized medicine. Clin Cancer Res 20:6233-41|
|Kremer, Kimberly N; Dudakovic, Amel; McGee-Lawrence, Meghan E et al. (2014) Osteoblasts protect AML cells from SDF-1-induced apoptosis. J Cell Biochem 115:1128-37|
|Karovic, S; Wen, Y; Karrison, T G et al. (2014) Sorafenib dose escalation is not uniformly associated with blood pressure elevations in normotensive patients with advanced malignancies. Clin Pharmacol Ther 96:27-35|
|Paller, Channing J; Bradbury, Penelope A; Ivy, S Percy et al. (2014) Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. Clin Cancer Res 20:4210-7|
|Chaudhuri, Leena; Vincelette, Nicole D; Koh, Brian D et al. (2014) CHK1 and WEE1 inhibition combine synergistically to enhance therapeutic efficacy in acute myeloid leukemia ex vivo. Haematologica 99:688-96|
|Dufresne, Simon F; Marr, Kieren A; Sydnor, Emily et al. (2014) Epidemiology of Candida kefyr in patients with hematologic malignancies. J Clin Microbiol 52:1830-7|
|Ding, Husheng; McDonald, Jennifer S; Yun, Seongseok et al. (2014) Farnesyltransferase inhibitor tipifarnib inhibits Rheb prenylation and stabilizes Bax in acute myelogenous leukemia cells. Haematologica 99:60-9|
Showing the most recent 10 out of 11 publications