Literature DB >> 34561269

Glioblastoma Clinical Trials: Current Landscape and Opportunities for Improvement.

Stephen J Bagley1, Shawn Kothari1, Rifaquat Rahman2, Eudocia Q Lee3, Gavin P Dunn4, Evanthia Galanis5, Susan M Chang6, Louis Burt Nabors7, Manmeet S Ahluwalia8, Roger Stupp9, Minesh P Mehta10, David A Reardon3, Stuart A Grossman11, Erik P Sulman12, John H Sampson13, Simon Khagi14, Michael Weller15, Timothy F Cloughesy16, Patrick Y Wen3, Mustafa Khasraw13.   

Abstract

Therapeutic advances for glioblastoma have been minimal over the past 2 decades. In light of the multitude of recent phase III trials that have failed to meet their primary endpoints following promising preclinical and early-phase programs, a Society for Neuro-Oncology Think Tank was held in November 2020 to prioritize areas for improvement in the conduct of glioblastoma clinical trials. Here, we review the literature, identify challenges related to clinical trial eligibility criteria and trial design in glioblastoma, and provide recommendations from the Think Tank. In addition, we provide a data-driven context with which to frame this discussion by analyzing key study design features of adult glioblastoma clinical trials listed on ClinicalTrials.gov as "recruiting" or "not yet recruiting" as of February 2021. ©2021 American Association for Cancer Research.

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Year:  2022        PMID: 34561269      PMCID: PMC9044253          DOI: 10.1158/1078-0432.CCR-21-2750

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN: 1078-0432            Impact factor:   13.801


  74 in total

Review 1.  Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.

Authors:  Patrick Y Wen; Michael Weller; Eudocia Quant Lee; Brian M Alexander; Jill S Barnholtz-Sloan; Floris P Barthel; Tracy T Batchelor; Ranjit S Bindra; Susan M Chang; E Antonio Chiocca; Timothy F Cloughesy; John F DeGroot; Evanthia Galanis; Mark R Gilbert; Monika E Hegi; Craig Horbinski; Raymond Y Huang; Andrew B Lassman; Emilie Le Rhun; Michael Lim; Minesh P Mehta; Ingo K Mellinghoff; Giuseppe Minniti; David Nathanson; Michael Platten; Matthias Preusser; Patrick Roth; Marc Sanson; David Schiff; Susan C Short; Martin J B Taphoorn; Joerg-Christian Tonn; Jonathan Tsang; Roel G W Verhaak; Andreas von Deimling; Wolfgang Wick; Gelareh Zadeh; David A Reardon; Kenneth D Aldape; Martin J van den Bent
Journal:  Neuro Oncol       Date:  2020-08-17       Impact factor: 12.300

2.  A randomized, double-blind, phase III trial of personalized peptide vaccination for recurrent glioblastoma.

Authors:  Yoshitaka Narita; Yoshiki Arakawa; Fumiyuki Yamasaki; Ryo Nishikawa; Tomokazu Aoki; Masayuki Kanamori; Motoo Nagane; Toshihiro Kumabe; Yuichi Hirose; Tomotsugu Ichikawa; Hiroyuki Kobayashi; Takamitsu Fujimaki; Hisaharu Goto; Hideo Takeshima; Tetsuya Ueba; Hiroshi Abe; Takashi Tamiya; Yukihiko Sonoda; Atsushi Natsume; Tatsuyuki Kakuma; Yasuo Sugita; Nobukazu Komatsu; Akira Yamada; Tetsuro Sasada; Satoko Matsueda; Shigeki Shichijo; Kyogo Itoh; Mizuhiko Terasaki
Journal:  Neuro Oncol       Date:  2019-02-19       Impact factor: 12.300

3.  Tumor Evolution of Glioma-Intrinsic Gene Expression Subtypes Associates with Immunological Changes in the Microenvironment.

Authors:  Qianghu Wang; Baoli Hu; Xin Hu; Hoon Kim; Massimo Squatrito; Lisa Scarpace; Ana C deCarvalho; Sali Lyu; Pengping Li; Yan Li; Floris Barthel; Hee Jin Cho; Yu-Hsi Lin; Nikunj Satani; Emmanuel Martinez-Ledesma; Siyuan Zheng; Edward Chang; Charles-Etienne Gabriel Sauvé; Adriana Olar; Zheng D Lan; Gaetano Finocchiaro; Joanna J Phillips; Mitchel S Berger; Konrad R Gabrusiewicz; Guocan Wang; Eskil Eskilsson; Jian Hu; Tom Mikkelsen; Ronald A DePinho; Florian Muller; Amy B Heimberger; Erik P Sulman; Do-Hyun Nam; Roel G W Verhaak
Journal:  Cancer Cell       Date:  2018-01-08       Impact factor: 31.743

4.  Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma.

Authors:  Hui K Gan; David A Reardon; Andrew B Lassman; Ryan Merrell; Martin van den Bent; Nicholas Butowski; Zarnie Lwin; Helen Wheeler; Lisa Fichtel; Andrew M Scott; Erica J Gomez; JuDee Fischer; Helen Mandich; Hao Xiong; Ho-Jin Lee; Wijith P Munasinghe; Lisa A Roberts-Rapp; Peter J Ansell; Kyle D Holen; Priya Kumthekar
Journal:  Neuro Oncol       Date:  2018-05-18       Impact factor: 12.300

5.  Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143.

Authors:  Antonio Omuro; Gordana Vlahovic; Michael Lim; Solmaz Sahebjam; Joachim Baehring; Timothy Cloughesy; Alfredo Voloschin; Shakti H Ramkissoon; Keith L Ligon; Robert Latek; Ricardo Zwirtes; Lewis Strauss; Prashni Paliwal; Christopher T Harbison; David A Reardon; John H Sampson
Journal:  Neuro Oncol       Date:  2018-04-09       Impact factor: 12.300

6.  Role of a second chemotherapy in recurrent malignant glioma patients who progress on bevacizumab.

Authors:  Eudocia C Quant; Andrew D Norden; Jan Drappatz; Alona Muzikansky; Lisa Doherty; Debra Lafrankie; Abigail Ciampa; Santosh Kesari; Patrick Y Wen
Journal:  Neuro Oncol       Date:  2009-03-30       Impact factor: 12.300

7.  Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement.

Authors:  Edward S Kim; Suanna S Bruinooge; Samantha Roberts; Gwynn Ison; Nancy U Lin; Lia Gore; Thomas S Uldrick; Stuart M Lichtman; Nancy Roach; Julia A Beaver; Rajeshwari Sridhara; Paul J Hesketh; Andrea M Denicoff; Elizabeth Garrett-Mayer; Eric Rubin; Pratik Multani; Tatiana M Prowell; Caroline Schenkel; Marina Kozak; Jeff Allen; Ellen Sigal; Richard L Schilsky
Journal:  J Clin Oncol       Date:  2017-10-02       Impact factor: 44.544

8.  DNA methylation-based classification of central nervous system tumours.

Authors:  David Capper; David T W Jones; Martin Sill; Volker Hovestadt; Daniel Schrimpf; Dominik Sturm; Christian Koelsche; Felix Sahm; Lukas Chavez; David E Reuss; Annekathrin Kratz; Annika K Wefers; Kristin Huang; Kristian W Pajtler; Leonille Schweizer; Damian Stichel; Adriana Olar; Nils W Engel; Kerstin Lindenberg; Patrick N Harter; Anne K Braczynski; Karl H Plate; Hildegard Dohmen; Boyan K Garvalov; Roland Coras; Annett Hölsken; Ekkehard Hewer; Melanie Bewerunge-Hudler; Matthias Schick; Roger Fischer; Rudi Beschorner; Jens Schittenhelm; Ori Staszewski; Khalida Wani; Pascale Varlet; Melanie Pages; Petra Temming; Dietmar Lohmann; Florian Selt; Hendrik Witt; Till Milde; Olaf Witt; Eleonora Aronica; Felice Giangaspero; Elisabeth Rushing; Wolfram Scheurlen; Christoph Geisenberger; Fausto J Rodriguez; Albert Becker; Matthias Preusser; Christine Haberler; Rolf Bjerkvig; Jane Cryan; Michael Farrell; Martina Deckert; Jürgen Hench; Stephan Frank; Jonathan Serrano; Kasthuri Kannan; Aristotelis Tsirigos; Wolfgang Brück; Silvia Hofer; Stefanie Brehmer; Marcel Seiz-Rosenhagen; Daniel Hänggi; Volkmar Hans; Stephanie Rozsnoki; Jordan R Hansford; Patricia Kohlhof; Bjarne W Kristensen; Matt Lechner; Beatriz Lopes; Christian Mawrin; Ralf Ketter; Andreas Kulozik; Ziad Khatib; Frank Heppner; Arend Koch; Anne Jouvet; Catherine Keohane; Helmut Mühleisen; Wolf Mueller; Ute Pohl; Marco Prinz; Axel Benner; Marc Zapatka; Nicholas G Gottardo; Pablo Hernáiz Driever; Christof M Kramm; Hermann L Müller; Stefan Rutkowski; Katja von Hoff; Michael C Frühwald; Astrid Gnekow; Gudrun Fleischhack; Stephan Tippelt; Gabriele Calaminus; Camelia-Maria Monoranu; Arie Perry; Chris Jones; Thomas S Jacques; Bernhard Radlwimmer; Marco Gessi; Torsten Pietsch; Johannes Schramm; Gabriele Schackert; Manfred Westphal; Guido Reifenberger; Pieter Wesseling; Michael Weller; Vincent Peter Collins; Ingmar Blümcke; Martin Bendszus; Jürgen Debus; Annie Huang; Nada Jabado; Paul A Northcott; Werner Paulus; Amar Gajjar; Giles W Robinson; Michael D Taylor; Zane Jaunmuktane; Marina Ryzhova; Michael Platten; Andreas Unterberg; Wolfgang Wick; Matthias A Karajannis; Michel Mittelbronn; Till Acker; Christian Hartmann; Kenneth Aldape; Ulrich Schüller; Rolf Buslei; Peter Lichter; Marcel Kool; Christel Herold-Mende; David W Ellison; Martin Hasselblatt; Matija Snuderl; Sebastian Brandner; Andrey Korshunov; Andreas von Deimling; Stefan M Pfister
Journal:  Nature       Date:  2018-03-14       Impact factor: 49.962

Review 9.  EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood.

Authors:  Michael Weller; Martin van den Bent; Matthias Preusser; Emilie Le Rhun; Jörg C Tonn; Giuseppe Minniti; Martin Bendszus; Carmen Balana; Olivier Chinot; Linda Dirven; Pim French; Monika E Hegi; Asgeir S Jakola; Michael Platten; Patrick Roth; Roberta Rudà; Susan Short; Marion Smits; Martin J B Taphoorn; Andreas von Deimling; Manfred Westphal; Riccardo Soffietti; Guido Reifenberger; Wolfgang Wick
Journal:  Nat Rev Clin Oncol       Date:  2020-12-08       Impact factor: 66.675

10.  Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of Cancer Research Joint Research Statement.

Authors:  Edward S Kim; Thomas S Uldrick; Caroline Schenkel; Suanna S Bruinooge; R Donald Harvey; Allison Magnuson; Alexander Spira; James L Wade; Mark D Stewart; Diana Merino Vega; Julia A Beaver; Andrea M Denicoff; Gwynn Ison; S Percy Ivy; Suzanne George; Raymond P Perez; Patricia A Spears; William D Tap; Richard L Schilsky
Journal:  Clin Cancer Res       Date:  2021-02-09       Impact factor: 12.531

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  7 in total

Review 1.  Novel Clinical Trial Designs in Neuro-Oncology.

Authors:  Anurag Saraf; Lorenzo Trippa; Rifaquat Rahman
Journal:  Neurotherapeutics       Date:  2022-08-15       Impact factor: 6.088

2.  The current state of glioma data registries.

Authors:  Alexander G Yearley; Julian Bryan Iorgulescu; Ennio Antonio Chiocca; Pier Paolo Peruzzi; Timothy R Smith; David A Reardon; Michael A Mooney
Journal:  Neurooncol Adv       Date:  2022-06-24

Review 3.  Leveraging extrachromosomal DNA to fine-tune trials of targeted therapy for glioblastoma: opportunities and challenges.

Authors:  Imran Noorani; Paul S Mischel; Charles Swanton
Journal:  Nat Rev Clin Oncol       Date:  2022-09-21       Impact factor: 65.011

Review 4.  Analysis of factors leading to early termination in glioblastoma-related clinical trials.

Authors:  Harshal A Shah; Akash Mishra; Michael J Gouzoulis; Netanel Ben-Shalom; Randy S D'Amico
Journal:  J Neurooncol       Date:  2022-06-01       Impact factor: 4.506

Review 5.  For whom the T cells troll? Bispecific T-cell engagers in glioblastoma.

Authors:  Kirit Singh; Kelly M Hotchkiss; Aditya A Mohan; Jessica L Reedy; John H Sampson; Mustafa Khasraw
Journal:  J Immunother Cancer       Date:  2021-11       Impact factor: 12.469

Review 6.  Osthole: An up-to-date review of its anticancer potential and mechanisms of action.

Authors:  Shaojie Yang; Wanlin Dai; Jingnan Wang; Xiaolin Zhang; Yuting Zheng; Shiyuan Bi; Liwei Pang; Tengqi Ren; Ye Yang; Yang Sun; Zhuyuan Zheng; Shuodong Wu; Jing Kong
Journal:  Front Pharmacol       Date:  2022-09-07       Impact factor: 5.988

7.  The miR-183/96/182 cluster is upregulated in glioblastoma carrying EGFR amplification.

Authors:  Björn Schneider; Doreen William; Nora Lamp; Annette Zimpfer; Christian Henker; Carl Friedrich Classen; Andreas Erbersdobler
Journal:  Mol Cell Biochem       Date:  2022-04-29       Impact factor: 3.842

  7 in total

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