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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: IOS Press 2016
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).
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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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