This application responds to RFA-CA-13-501 which is intended to continue the National Cancer Institute's effort to develop new therapies for adults with high grade gliomas. During the past five years, the ABTC has demonstrated that it is an efficient and capable early phase clinical trial organization able to conduct outstanding science. The ABTC will remain focused on early stage drug development and will use its scientific and clinical trial expertise, patient and laboratory resources, and biospecimens to conduct pharmacokinetic (PK), pharmacodynamic (PD), and imaging studies to characterize drug effects on relevant cellular targets. The consortium has a 20 year history of timely development and activation of multisite pilot and phase I/II brain tumor trials, outstanding data management, and an extensive publication record. It involves talented investigators from multiple disciplines, research nurses, and data managers from 11 brain tumor centers with a proven history of productive relationships with the ABTC Central Operations Office. The ABTC will be led by Drs. Grossman, Nabors, and Wen and a diverse and qualified Consortium Coordinating Committee. The Central Operations Office will be directed by Dr. Grossman and Joy Fisher and Dr. Ye will oversee ABTC's biostatistics. The Clinical Trials Research Program, chaired by Drs. Nabors and Wen, consists of a Research Concept Committee and 10 Discipline Committees (Drug delivery, Immunology, Genomic Profiling, Imaging, Neuropathology, Neurosurgery, PK, PD &Correlative Biology, Preclinical Drug Screening, and Radiation Oncology) chaired by nationally recognized experts. The ABTC has formal mechanisms to dismiss underperforming sites, evaluate new member and """"""""guest"""""""" sites, and review and fund competitive correlative biology research. The ABTC will continue to foster interactions with the NIH, SPOREs, cooperative groups, academic translational research, and industry. An experienced Advisory Panel will provide critical input. The ABTC's goal is to develop more effective therapies by safely and efficiently introducing novel treatment approaches through pilot and phase I/II clinical trials, integrating appropriate PK and PD endpoints into clinical trials, and collaborating with other NCI-funded researchers.

Public Health Relevance

The Adult Brain Tumor Consortium (ABTC) is designed to develop more effective treatments for adults with brain cancers. It is comprised of a Central Operations Office, a Clinical Trials Research Program, and 11 brain tumor centers. It will introduce novel therapies using early phase clinical trials, collaborate with other researchers and clinical trial groups, and incorporate pharmacokinetic and pharmacodynamic endpoints.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Timmer, William C
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Johns Hopkins University
Internal Medicine/Medicine
Schools of Medicine
United States
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Nghiemphu, Phioanh Leia; Ebiana, Victoria Asuquo; Wen, Patrick et al. (2018) Phase I study of sorafenib and tipifarnib for recurrent glioblastoma: NABTC 05-02. J Neurooncol 136:79-86
Nowosielski, Martha; Wen, Patrick Y (2018) Imaging Criteria in Neuro-oncology. Semin Neurol 38:24-31
Blakeley, Jaishri O; Grossman, Stuart A; Chi, Andrew S et al. (2018) Phase II Study of Iniparib with Concurrent Chemoradiation in Patients with Newly Diagnosed Glioblastoma. Clin Cancer Res :
Wen, Patrick Y; Chang, Susan M; Van den Bent, Martin J et al. (2017) Response Assessment in Neuro-Oncology Clinical Trials. J Clin Oncol 35:2439-2449
Holdhoff, Matthias; Ye, Xiaobu; Supko, Jeffrey G et al. (2017) Timed sequential therapy of the selective T-type calcium channel blocker mibefradil and temozolomide in patients with recurrent high-grade gliomas. Neuro Oncol 19:845-852
Lodge, Martin A; Holdhoff, Matthias; Leal, Jeffrey P et al. (2017) Repeatability of (18)F-FLT PET in a Multicenter Study of Patients with High-Grade Glioma. J Nucl Med 58:393-398
Nayak, Lakshmi; de Groot, John; Wefel, Jeffrey S et al. (2017) Phase I trial of aflibercept (VEGF trap) with radiation therapy and concomitant and adjuvant temozolomide in patients with high-grade gliomas. J Neurooncol 132:181-188
Pan, Edward; Supko, Jeffrey G; Kaley, Thomas J et al. (2016) Phase I study of RO4929097 with bevacizumab in patients with recurrent malignant glioma. J Neurooncol 130:571-579
Kleinberg, L R; Stieber, V; Mikkelsen, T et al. (2015) Outcome of Adult Brain Tumor Consortium (ABTC) prospective dose-finding trials of I-125 balloon brachytherapy in high-grade gliomas: challenges in clinical trial design and technology development when MRI treatment effect and recurrence appear similar. J Radiat Oncol 4:235-241
Gerstner, Elizabeth R; Ye, Xiaobu; Duda, Dan G et al. (2015) A phase I study of cediranib in combination with cilengitide in patients with recurrent glioblastoma. Neuro Oncol 17:1386-92

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