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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
1UM1CA186691-01
Application #
8725327
Study Section
Special Emphasis Panel (ZCA1-RTRB-E (J1))
Program Officer
Ivy, S Percy
Project Start
2014-03-13
Project End
2019-02-28
Budget Start
2014-03-13
Budget End
2015-02-28
Support Year
1
Fiscal Year
2014
Total Cost
$850,000
Indirect Cost
$175,397
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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