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Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer
The NCI Bladder Cancer Task Force convened a Clinical Trials Planning Meeting (CTPM) Workshop focused on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer (NMIBC). Meeting attendees included a broad and multi-disciplinary group of clinical and research stakeholders and included leaders from...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
IOS Press
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927845/ https://www.ncbi.nlm.nih.gov/pubmed/27376138 http://dx.doi.org/10.3233/BLC-160053 |
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author | Lerner, Seth P. Bajorin, Dean F. Dinney, Colin P. Efstathiou, Jason A. Groshen, Susan Hahn, Noah M. Hansel, Donna Kwiatkowski, David O’Donnell, Michael Rosenberg, Jonathan Svatek, Robert Abrams, Jeffrey S. Al-Ahmadie, Hikmat Apolo, Andrea B. Bellmunt, Joaquim Callahan, Margaret Cha, Eugene K. Drake, Charles Jarow, Jonathan Kamat, Ashish Kim, William Knowles, Margaret Mann, Bhupinder Marchionni, Luigi McConkey, David McShane, Lisa Ramirez, Nilsa Sharabi, Andrew Sharpe, Arlene H. Solit, David Tangen, Catherine M. Amiri, Abdul Tawab Van Allen, Eliezer West, Pamela J. Witjes, J. A. Quale, Diane Zipursky |
author_facet | Lerner, Seth P. Bajorin, Dean F. Dinney, Colin P. Efstathiou, Jason A. Groshen, Susan Hahn, Noah M. Hansel, Donna Kwiatkowski, David O’Donnell, Michael Rosenberg, Jonathan Svatek, Robert Abrams, Jeffrey S. Al-Ahmadie, Hikmat Apolo, Andrea B. Bellmunt, Joaquim Callahan, Margaret Cha, Eugene K. Drake, Charles Jarow, Jonathan Kamat, Ashish Kim, William Knowles, Margaret Mann, Bhupinder Marchionni, Luigi McConkey, David McShane, Lisa Ramirez, Nilsa Sharabi, Andrew Sharpe, Arlene H. Solit, David Tangen, Catherine M. Amiri, Abdul Tawab Van Allen, Eliezer West, Pamela J. Witjes, J. A. Quale, Diane Zipursky |
author_sort | Lerner, Seth P. |
collection | PubMed |
description | The NCI Bladder Cancer Task Force convened a Clinical Trials Planning Meeting (CTPM) Workshop focused on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer (NMIBC). Meeting attendees included a broad and multi-disciplinary group of clinical and research stakeholders and included leaders from NCI, FDA, National Clinical Trials Network (NCTN), advocacy and the pharmaceutical and biotech industry. The meeting goals and objectives were to: 1) create a collaborative environment in which the greater bladder research community can pursue future optimally designed novel clinical trials focused on the theme of molecular targeted and immune-based therapies in NMIBC; 2) frame the clinical and translational questions that are of highest priority; and 3) develop two clinical trial designs focusing on immunotherapy and molecular targeted therapy. Despite successful development and implementation of large Phase II and Phase III trials in bladder and upper urinary tract cancers, there are no active and accruing trials in the NMIBC space within the NCTN. Disappointingly, there has been only one new FDA approved drug (Valrubicin) in any bladder cancer disease state since 1998. Although genomic-based data for bladder cancer are increasingly available, translating these discoveries into practice changing treatment is still to come. Recently, major efforts in defining the genomic characteristics of NMIBC have been achieved. Aligned with these data is the growing number of targeted therapy agents approved and/or in development in other organ site cancers and the multiple similarities of bladder cancer with molecular subtypes in these other cancers. Additionally, although bladder cancer is one of the more immunogenic tumors, some tumors have the ability to attenuate or eliminate host immune responses. Two trial concepts emerged from the meeting including a window of opportunity trial (Phase 0) testing an FGFR3 inhibitor and a second multi-arm multi-stage trial testing combinations of BCG or radiotherapy and immunomodulatory agents in patients who recur after induction BCG (BCG failure). |
format | Online Article Text |
id | pubmed-4927845 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | IOS Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-49278452016-06-30 Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer Lerner, Seth P. Bajorin, Dean F. Dinney, Colin P. Efstathiou, Jason A. Groshen, Susan Hahn, Noah M. Hansel, Donna Kwiatkowski, David O’Donnell, Michael Rosenberg, Jonathan Svatek, Robert Abrams, Jeffrey S. Al-Ahmadie, Hikmat Apolo, Andrea B. Bellmunt, Joaquim Callahan, Margaret Cha, Eugene K. Drake, Charles Jarow, Jonathan Kamat, Ashish Kim, William Knowles, Margaret Mann, Bhupinder Marchionni, Luigi McConkey, David McShane, Lisa Ramirez, Nilsa Sharabi, Andrew Sharpe, Arlene H. Solit, David Tangen, Catherine M. Amiri, Abdul Tawab Van Allen, Eliezer West, Pamela J. Witjes, J. A. Quale, Diane Zipursky Bl Cancer Meeting Report The NCI Bladder Cancer Task Force convened a Clinical Trials Planning Meeting (CTPM) Workshop focused on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer (NMIBC). Meeting attendees included a broad and multi-disciplinary group of clinical and research stakeholders and included leaders from NCI, FDA, National Clinical Trials Network (NCTN), advocacy and the pharmaceutical and biotech industry. The meeting goals and objectives were to: 1) create a collaborative environment in which the greater bladder research community can pursue future optimally designed novel clinical trials focused on the theme of molecular targeted and immune-based therapies in NMIBC; 2) frame the clinical and translational questions that are of highest priority; and 3) develop two clinical trial designs focusing on immunotherapy and molecular targeted therapy. Despite successful development and implementation of large Phase II and Phase III trials in bladder and upper urinary tract cancers, there are no active and accruing trials in the NMIBC space within the NCTN. Disappointingly, there has been only one new FDA approved drug (Valrubicin) in any bladder cancer disease state since 1998. Although genomic-based data for bladder cancer are increasingly available, translating these discoveries into practice changing treatment is still to come. Recently, major efforts in defining the genomic characteristics of NMIBC have been achieved. Aligned with these data is the growing number of targeted therapy agents approved and/or in development in other organ site cancers and the multiple similarities of bladder cancer with molecular subtypes in these other cancers. Additionally, although bladder cancer is one of the more immunogenic tumors, some tumors have the ability to attenuate or eliminate host immune responses. Two trial concepts emerged from the meeting including a window of opportunity trial (Phase 0) testing an FGFR3 inhibitor and a second multi-arm multi-stage trial testing combinations of BCG or radiotherapy and immunomodulatory agents in patients who recur after induction BCG (BCG failure). IOS Press 2016-04-27 /pmc/articles/PMC4927845/ /pubmed/27376138 http://dx.doi.org/10.3233/BLC-160053 Text en IOS Press and the authors. All rights reserved https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial (CC BY-NC 4.0) License (https://creativecommons.org/licenses/by-nc/4.0/) , which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Meeting Report Lerner, Seth P. Bajorin, Dean F. Dinney, Colin P. Efstathiou, Jason A. Groshen, Susan Hahn, Noah M. Hansel, Donna Kwiatkowski, David O’Donnell, Michael Rosenberg, Jonathan Svatek, Robert Abrams, Jeffrey S. Al-Ahmadie, Hikmat Apolo, Andrea B. Bellmunt, Joaquim Callahan, Margaret Cha, Eugene K. Drake, Charles Jarow, Jonathan Kamat, Ashish Kim, William Knowles, Margaret Mann, Bhupinder Marchionni, Luigi McConkey, David McShane, Lisa Ramirez, Nilsa Sharabi, Andrew Sharpe, Arlene H. Solit, David Tangen, Catherine M. Amiri, Abdul Tawab Van Allen, Eliezer West, Pamela J. Witjes, J. A. Quale, Diane Zipursky Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer |
title | Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer |
title_full | Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer |
title_fullStr | Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer |
title_full_unstemmed | Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer |
title_short | Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer |
title_sort | summary and recommendations from the national cancer institute’s clinical trials planning meeting on novel therapeutics for non-muscle invasive bladder cancer |
topic | Meeting Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927845/ https://www.ncbi.nlm.nih.gov/pubmed/27376138 http://dx.doi.org/10.3233/BLC-160053 |
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