Journal article
Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer
Bladder cancer, Vol.2(2), pp.165-202
2016
DOI: 10.3233/BLC-160053
PMID: 27376138
Abstract
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).
Details
- Title: Subtitle
- Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer
- Creators
- Seth P Lerner - , Houston, TXDean F Bajorin - , New York, NYColin P Dinney - , Houston, TXJason A Efstathiou - , Harvard Medical School, Boston, MASusan Groshen - USC Norris Comprehensive Cancer CenterNoah M Hahn - , Baltimore, MDDonna Hansel - , La Jolla, San Diego, CADavid Kwiatkowski - , Harvard Medical School, Boston, MAMichael O’Donnell - , IAJonathan Rosenberg - , New York, NYRobert Svatek - , San Antonio, TXJeffrey S Abrams - Cancer Therapy Evaluation Program, Division of Cancer Treatment and DiagnosisHikmat Al-Ahmadie - , New York, NYAndrea B Apolo - Genitourinary Malignancies Branch, Center for Cancer ResearchJoaquim Bellmunt - , Boston, MAMargaret Callahan - , New York, NYEugene K Cha - , New York, NYCharles Drake - , Baltimore, MDJonathan Jarow - , U.S. Food and Drug Administration, Silver Spring, MDAshish Kamat - , Houston, TXWilliam Kim - , Chapel Hill, NCMargaret Knowles - , University of Leeds, Leeds, UKBhupinder Mann - Cancer Therapy Evaluation Program, Division of Cancer Treatment and DiagnosisLuigi Marchionni - , Baltimore, MDDavid McConkey - , Houston, TXLisa McShane - Biometric Research Branch, Division of Cancer Treatment and DiagnosisNilsa Ramirez - , Columbus, OHAndrew Sharabi - USC Norris Comprehensive Cancer CenterArlene H Sharpe - , Boston, MADavid Solit - , New York, NYCatherine M Tangen - , Fred Hutchinson Cancer Research Center, Seattle, WAAbdul Tawab Amiri - , Houston, TXEliezer Van Allen - , Boston, MAPamela J West - , Rockville, MDJ. A Witjes - Department of Urology, Radboud UMC, Nijmegen, The NetherlandsDiane Zipursky Quale - , Bethesda, MD
- Resource Type
- Journal article
- Publication Details
- Bladder cancer, Vol.2(2), pp.165-202
- Publisher
- IOS Press
- DOI
- 10.3233/BLC-160053
- PMID
- 27376138
- ISSN
- 2352-3727
- eISSN
- 2352-3727
- Language
- English
- Date published
- 2016
- Academic Unit
- Urology
- Record Identifier
- 9984051554202771
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