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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Streiff, Michael B; Ye, Xiaobu; Kickler, Thomas S et al. (2015) A prospective multicenter study of venous thromboembolism in patients with newly-diagnosed high-grade glioma: hazard rate and risk factors. J Neurooncol 124:299-305
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
Blakeley, Jaishri O; Grossman, Stuart A; Mikkelsen, Tom et al. (2015) Phase I study of iniparib concurrent with monthly or continuous temozolomide dosing schedules in patients with newly diagnosed malignant gliomas. J Neurooncol 125:123-31
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
Lathia, Justin D; Li, Meizhang; Sinyuk, Maksim et al. (2014) High-throughput flow cytometry screening reveals a role for junctional adhesion molecule a as a cancer stem cell maintenance factor. Cell Rep 6:117-29
Rosenfeld, Myrna R; Ye, Xiaobu; Supko, Jeffrey G et al. (2014) A phase I/II trial of hydroxychloroquine in conjunction with radiation therapy and concurrent and adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme. Autophagy 10:1359-68
Hale, James S; Otvos, Balint; Sinyuk, Maksim et al. (2014) Cancer stem cell-specific scavenger receptor CD36 drives glioblastoma progression. Stem Cells 32:1746-58
Shonka, Nicole; Piao, Yuji; Gilbert, Mark et al. (2013) Cytokines associated with toxicity in the treatment of recurrent glioblastoma with aflibercept. Target Oncol 8:117-25
Nayak, Lakshmi; Abrey, Lauren E; Drappatz, Jan et al. (2013) Multicenter phase II study of rituximab and temozolomide in recurrent primary central nervous system lymphoma. Leuk Lymphoma 54:58-61
Kim, Youngmi; Wu, Qiulian; Hamerlik, Petra et al. (2013) Aptamer identification of brain tumor-initiating cells. Cancer Res 73:4923-36

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