ZID BC 011642 (ZID) | |||
---|---|---|---|
Title | Brain Tumor Clinical and Clinical Research Program | ||
Institution | NCI, Bethesda, MD | ||
Principal Investigator | Gilbert, Mark | NCI Program Director | N/A |
Cancer Activity | N/A | Division | CCR |
Funded Amount | $1,553,246 | Project Dates | 00/00/0000 - 00/00/0000 |
Fiscal Year | 2017 | Project Type | Intramural |
Research Topics w/ Percent Relevance | Cancer Types w/ Percent Relevance | ||
Cancer (100.0%) |
Brain (80.0%) Central Nervous System - Not Including Brain (20.0%) Nervous System (100.0%) |
||
Research Type | |||
Systemic Therapies - Clinical Applications Patient Care and Survivorship Issues |
|||
Abstract | |||
The NOB has made substantial progress towards building an infrastructure necessary for fulfilling its mission of developing new and improved therapies for children and adults with brain and spinal cord tumors. Since Dr. Gilbert's arrival at the NIH in November 2014, he has rebuilt the Brain Tumor Clinical and Clinical Research Program: a highly collaborative, robust translational research program centered on finding treatments for brain and other central nervous system tumors. In addition to conducting basic and translational research, the NOB has become a nationally recognized resource for patient information and referrals for second opinions. In addition to seeing and treating brain tumor patients, Dr. Gilbert currently runs a significant number of national clinical trials and helps organize and administrate over several large national Neuro-Oncology translational science initiatives. Recently, Dr. Gilbert led RTOG 0825 which evaluated the role of the anti-angiogenic agent, bevacizumab, in patients with newly diagnosed glioblastoma in a double-blind placebo controlled randomized phase III trial. This study accrued 973 patients and successfully incorporated upfront stratification by two molecular parameters, as there was 100% compliance with tumor tissue submission. This study, which did not demonstrate a survival benefit for bevacizumab, demonstrated neurocognitive decline and worsened symptom burden and quality of life in the patients treated with bevacizumab. This study was presented at the Plenary Session at ASCO and published in the New England Journal of Medicine. These efforts have led to his leadership of NRG BN002, a clinical trial that is testing the safety of adding the immune checkpoint inhibitors, ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) in patients with newly diagnosed glioblastoma. This is the prelude to definitive randomized, placebo-controlled trial that will determine whether these immune checkpoint inhibitors have efficacy in glioblastoma. A critical component of the trial will be the immunologic monitoring which will comprise testing of tumor tissue for mediators of immune-reactivity and serial monitoring of peripheral blood mononuclear cells as an indicator of the impact of treatment on ""immune competence"". This work will be done in the NOB Lab in close collaboration with the Laboratory of Tumor Immunology and Biology led by Dr. Jeffrey Schlom. Dr. Gilbert has also transitioned the Brain Tumor Trials Collaborative (BTTC) from M. D. Anderson Cancer Center. This is a national consortium that was founded on philanthropic support. The mission of the BTTC is to rapidly develop and complete innovative clinical trials for patients with primary brain tumors. To date, the BTTC has completed a study that used a factorial design (8 treatment arms were evaluated simultaneously) and a trial that used an adaptive randomized design (patient allocation based on treatment efficacy using patient by patient rebalancing). This effort is currently being transferred from the M. D. Anderson Cancer Center to the NCI. There are currently 3 active studies and once relaunched, and addition study concepts are anticipated. The list of participating sites is provided below: Aurora Advanced Healthcare, National Institutes of Health, Baylor University, Northwestern University, Feinberg School of Medicine, Case Western Reserve SOM, Ohio State University, Cedar-Sinai Medical Center, Rush University Cancer Center, Cleveland Clinic, Texas Oncology, Columbia University, The Methodist Hospital, Dana Farber Cancer Institute, University of North Carolina, Henry Ford Health System, University of Kansas, Medical University of South Carolina, University of Utah, Orlando Health, University of Washington, Mayo Clinic, UT M. D. Anderson Cancer Center, Northshore University Health System, UT Southwestern Medical Center at Dallas. The NOB has created a vibrant, robust and clinically busy center for neuro-oncology excellence that serves as a n |