The Atlantic Coast Phase 2 Consortium (ACP2C) with Johns Hopkins serving as the lead academic organization (LAO) will expand upon the existing Johns Hopkins UM1-funded phase I trials infrastructure to conduct highly translational phase 2 trials of promising new therapies for patients with malignant disease in a clinically efficient, regulatory compliant, and scientifically rigorous collaborative research environment. Building upon a strong foundation in the conduct of early phase trials, we have assembled an interactive and interdisciplinary phase 2 team from six geographically and scientifically aligned NCI-designated cancer centers: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (JHKCC)(LAO), Emory Winship Cancer Institute (EWCI), Georgetown Lombardi Comprehensive Cancer Center (LCCC), Memorial Sloan Kettering Cancer Center (MSKCC), Sidney Kimmel Cancer Center at Thomas Jefferson University (TJU), and University of Virginia Cancer Center (UVACC). The ACP2C has five aims:
Aim1 - To contribute collaboratively and actively in the NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) with Phase II Emphasis as a team member through an expanded Hopkins-led Consortium.;
Aim 2 - To conduct informative Phase ll clinical trials of novel anti-cancer agents in a timely manner.;
Aim 3 -To incorporate and implement innovative correlative and biological laboratory studies in the context of or as eligibility for participation in Phase II studies to enhance our understanding of determinants of toxicity and response that will be used for further definitive practice-changing clinical trial evaluation.;
Aim 4 - To maintain a coordinated clinical trial infrastructure that is current and compliant with regulatory standards to assure quality care to patients enrolled on early phase clinical trials as well as provide prompt data sharing with other investigators and interested parties.;
and Aim 5 - To train the next generation of investigators in drug development. Through these aims and with a focus on team science and collaboration across ACP2C led phase 2 trials, the Johns Hopkins leadership of this UM1 supplement is committed to the success of the NCI ETCTN. We anticipate that we will easily meet the required 100 phase 2 patients/year accrual. We will support the ETCTN 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 expand upon its long-standing contribution to the drug development efforts of the NCI Experimental-Therapeutics Clinical Trials Network (ETCTN) through the creation of the Atlantic Coast Phase 2 Consortium (ACP2C), a collaboration of scientifically aligned NCI-designated cancer centers which have coalesced with the uniform goal of conducting highly translational phase 2 clinical trials of NCI ETCTN novel therapeutics. We anticipate that the ACP2C contributions 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/Alliance primary affiliations 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 #
3UM1CA186691-03S1
Application #
9095782
Study Section
Special Emphasis Panel ()
Program Officer
Ivy, S Percy
Project Start
2014-03-13
Project End
2019-02-28
Budget Start
2016-03-21
Budget End
2017-02-28
Support Year
3
Fiscal Year
2016
Total Cost
$872,709
Indirect Cost
$80,018
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
Levis, Mark J; Perl, Alexander E; Altman, Jessica K et al. (2018) A next-generation sequencing-based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations. Blood Adv 2:825-831
Liu, Tao; Ivaturi, Vijay; Sabato, Philip et al. (2018) Sorafenib Dose Recommendation in Acute Myeloid Leukemia Based on Exposure-FLT3 Relationship. Clin Transl Sci 11:435-443
Pietanza, M Catherine; Waqar, Saiama N; Krug, Lee M et al. (2018) Randomized, Double-Blind, Phase II Study of Temozolomide in Combination With Either Veliparib or Placebo in Patients With Relapsed-Sensitive or Refractory Small-Cell Lung Cancer. J Clin Oncol 36:2386-2394
Yeruva, Sri Lakshmi Hyndavi; Zhao, Fengmin; Miller, Kathy D et al. (2018) E2112: randomized phase iii trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. NPJ Breast Cancer 4:1
Day, Daphne; Monjazeb, Arta M; Sharon, Elad et al. (2017) From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely. Clin Cancer Res 23:4980-4991
Pili, Roberto; Quinn, David I; Hammers, Hans J et al. (2017) Immunomodulation by Entinostat in Renal Cell Carcinoma Patients Receiving High-Dose Interleukin 2: A Multicenter, Single-Arm, Phase I/II Trial (NCI-CTEP#7870). Clin Cancer Res 23:7199-7208
Weber, Jeffrey S; Levit, Laura A; Adamson, Peter C et al. (2017) Reaffirming and Clarifying the American Society of Clinical Oncology's Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment. J Clin Oncol 35:139-140
Connolly, Roisin M; Li, Huili; Jankowitz, Rachel C et al. (2017) Combination Epigenetic Therapy in Advanced Breast Cancer with 5-Azacitidine and Entinostat: A Phase II National Cancer Institute/Stand Up to Cancer Study. Clin Cancer Res 23:2691-2701
Mehrotra, Shailly; Gopalakrishnan, Mathangi; Gobburu, Jogarao et al. (2017) Population pharmacokinetics and site of action exposures of veliparib with topotecan plus carboplatin in patients with haematological malignancies. Br J Clin Pharmacol 83:1688-1700
Mehrotra, Shailly; Gopalakrishnan, Mathangi; Gobburu, Jogarao et al. (2017) Exposure-Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies. Clin Cancer Res 23:6421-6429

Showing the most recent 10 out of 49 publications