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2020

Phase II results from a phase I/II study to assess the safety and efficacy of weekly nab-paclitaxel in paediatric patients with recurrent or refractory solid tumours: A collaboration with the European Innovative Therapies for Children with Cancer Network

Loredana Amoroso a, *, Victoria Castel b , Gianni Bisogno c , Michela Casanova d , Catalina Marquez-Vega e , Julia C. Chisholm f , Franc¸ois Doz g , Lucas Moreno h,i , Antonio Ruggiero j , Nicolas U. Gerber k , Franca Fagioli l,m, Pooja Hingorani n , Soledad G. Melco´n i , Ruta Slepetis o , Nianhang Chen o , Yvan le Bruchec p , Mathew Simcock p , Gilles Vassal Published:June 15, 2020DOI:https://doi.org/10.1016/j.ejca.2020.04.031

 

Accelerating drug development for neuroblastoma: Summary of the Second Neuroblastoma Drug Development Strategy forum from Innovative Therapies for Children with Cancer and International Society of Paediatric Oncology Europe Neuroblastoma

Lucas Moreno a, *,1 , Giuseppe Barone b,1 , Steven G. DuBois c,1 , Jan Molenaar d , Matthias Fischer e,f , Johannes Schulte g , Angelika Eggert g,h,i , Gudrun Schleiermacher j , Frank Speleman k , Louis Chesler l,m, Birgit Geoerger n , Michael D. Hogarty o,y , Meredith S. Irwin p , Nick Bird q , Guy B. Blanchard r , Sean Buckland s , Hubert Caron t , Susan Davis u , Bram De Wilde k , Hedwig E. Deubzer f , Emmy Dolman v , Martin Eilers w, Rani E. George c , Sally George l,m, St  erba Jaroslav x , John M. Maris o,y , Lynley Marshall l,m, Melinda Merchant z , Peter Mortimer z , Cormac Owens aa, Anna Philpott ab, Evon Poon m, Jerry W. Shay ac, Roberto Tonelli ad, Dominique Valteau-Couanet n , Gilles Vassal ae, Julie R. Park af,2 , Andrew D.J. Pearson Published:July 09, 2020DOI:https://doi.org/10.1016/j.ejca.2020.05.010

 

2018

Outcome of children and adolescents with central nervous system tumors in phase I trials

Fernando Carceller, Francisco Bautista, Irene Jiménez, Raquel Hladun-Álvaro, Cécile Giraud, Luca Bergamaschi, Madhumita Dandapani, Isabelle Aerts, François Doz, Didier Frappaz, Michela Casanova, Bruce Morland, Darren R. Hargrave, Gilles Vassal, Andrew D. J. Pearson, Birgit Geoerger, Lucas Moreno & Lynley V. Marshall

Journal of Neuro-Oncology volume 137, pages83–92 (2018)

 

10-year report on the European Paediatric Regulation and its impact on new drugs for children's cancers

Andrew DJ Pearson Delphine Heenen Pamela R Kearns Anne Goeres Lynley V Marshall Patricia Blanc Gilles Vassal

Published:March, 2018DOI:https://doi.org/10.1016/S1470-2045(18)30105-0

 

Phase I results of a phase I/II study of weekly nabpaclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer

Lucas Moreno a, *,1 , Michela Casanova b,1 , Julia C. Chisholm c , Pablo Berlanga d , Pascal B. Chastagner e , Sylvain Baruchel f , Loredana Amoroso g , Soledad Gallego Melco´n h , Nicolas U. Gerber i , Gianni Bisogno j , Franca Fagioli k , Birgit Geoerger l , Julia L. Glade Bender m, Isabelle Aerts n , Christophe Bergeron o , Pooja Hingorani p , Ileana Elias q , Mathew Simcock r , Stefano Ferrara r , Yvan Le Bruchec r , Ruta Slepetis s , Nianhang Chen s , Gilles Vassal Published:June 21, 2018DOI:https://doi.org/10.1016/j.ejca.2018.05.002

 

A phase 1/2, open-label, dose-escalation study of midostaurin in children with relapsed or refractory acute leukaemia

C. Michel Zwaan, Stefan Söderhäll, Benoit Brethon, Matteo Luciani, Carmelo Rizzari, Ronald W. Stam, Emmanuelle Besse, Catherine Dutreix, Franca Fagioli, Phoenix A. Ho, Carlo Dufour, Rob Pieters

First published: 11 September 2018 https://doi.org/10.1111/bjh.15593

 

2017

Early phase clinical trials of anticancer agents in children and adolescents — an ITCC perspective

Lucas Moreno, Andrew D. J. Pearson, Xavier Paoletti, Irene Jimenez, Birgit Geoerger, Pamela R. Kearns, C. Michel Zwaan, Francois Doz, Andre Baruchel, Josef Vormoor, Michela Casanova, Stefan M. Pfister, Bruce Morland & Gilles Vassal on behalf of the Innovative Therapies for Children with Cancer (ITCC) Consortium

Nature Reviews Clinical Oncology volume 14, pages497–507 (2017)

 

2013

Phase II study of irinotecan in combination with temozolomide (TEMIRI) in children with recurrent or refractory medulloblastoma: a joint ITCC and SIOPE brain tumor study.

Grill J, Geoerger B, Gesner L, Perek D, Leblond P, Cañete A, Aerts I, Madero L, de Toledo Codina JS, Verlooy J, Estlin E, Cisar L, Breazna A, Dorman A, Bailey S, Nicolin G, Grundy RG, Hargrave D; European Consortium Innovative Therapies for Children with Cancer (ITCC) and the European Society for Paediatric Oncology (SIOPE) brain tumor group.
Neuro Oncol. 2013 Sep;15(9):1236-43. doi: 10.1093/neuonc/not097. Epub 2013 Jul 14.

 

A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: a joint ITCC and SIOPE-brain tumour study.

Hargrave D, Geoerger B, Frappaz D, Pietsch T, Gesner L, Cisar L, Breazna A, Dorman A, Cruz-Martinez O, Fuster JL, Rialland X, Icher C, Leblond P, Ashley D, Perilongo G, Elliott M, English M, Clausen N, Grill J.
J Neurooncol. 2013 May;113(1):127-34. doi: 10.1007/s11060-013-1098-2. Epub 2013 Mar 4.


Phase II study of temozolomide in combination with topotecan (TOTEM) in relapsed or refractory neuroblastoma: A European Innovative Therapies for Children with Cancer-SIOP-European Neuroblastoma study

Angela Di Giannatale a,1, Nathalie Dias-Gastellier a,1, Annick Devos b,1, Kieran Mc Hugh c,1, Ariane Boubaker d,1, Frederic Courbon e,1, Arnaud Verschuur f,1, Ste´phane Ducassoul g,1, Katty Malekzadeh a,1, Michela Casanova h,1, Loredana Amoroso i,1, Pascal Chastagner j,1, Christian M. Zwaan b,1, Caroline Munzer k,1, Isabelle Aerts n,1, Judith Landman-Parker l,1, Riccardo Riccardi m,1, Marie-Cecile Le Deley a,1, Birgit Geoerger a,1, Herve´ Rubie k,⇑,1DOI: https://doi.org/10.1016/j.ejca.2013.08.012

Dasatinib in Children and Adolescents with Relapsed or Refractory Leukemia: Results of the CA180018 Phase I Dose-Escalation Study of the ‘Innovative Therapies for Children with Cancer’ Consortium. 

C. Michel Zwaan, Carmelo Rizzari, Francoise Mechinaud, Donna L. Lancaster, Thomas Lehrnbecher, Vincent H.J. van der Velden, B. Berna Beverloo, Monique L. den Boer, Rob Pieters, Dirk Reinhardt, Michael Dworzak, Julie Rosenberg, George Manos, Shruti Agrawal, Lewis Strauss, Andre´ Baruchel, and Pamela R. Kearns. J Clin Oncol, 2013 May 28

2012

A phase I and pharmacokinetic study of plitidepsin in children with advanced solid tumours: an Innovative Therapies for Children with Cancer (ITCC) study.

Geoerger B, Estlin EJ, Aerts I, Kearns P, Gibson B, Corradini N, Doz F, Lardelli P, Miguel BD, Soto A, Prados R, Vassal G.
Eur J Cancer. 2012 Feb;48(3):289-96. Epub 2011 Nov 24.

 
2011

Innovative Therapies for Children with Cancer pediatric phase I study of erlotinib in brainstem glioma and relapsing/refractory brain tumors.

Geoerger B, Hargrave D, Thomas F, Ndiaye A, Frappaz D, Andreiuolo F, Varlet P, Aerts I, Riccardi R, Jaspan T, Chatelut E, Le Deley MC, Paoletti X, Saint-Rose C, Leblond P, Morland B, Gentet JC, Méresse V, Vassal G; ITCC (Innovative Therapies for Children with Cancer) European Consortium.
Neuro Oncol. 2011 Jan;13(1):109-18. Epub 2010 Oct 25.

 

Phase II study of gemcitabine combined with oxaliplatin in relapsed or refractory paediatric solid malignancies: An innovative therapy for children with Cancer European Consortium Study.

Geoerger B, Chisholm J, Le Deley MC, Gentet JC, Zwaan CM, Dias N, Jaspan T, Mc Hugh K, Couanet D, Hain S, Devos A, Riccardi R, Cesare C, Boos J, Frappaz D, Leblond P, Aerts I, Vassal G; European Consortium Innovative Therapies for Children with Cancer (ITCC).
Eur J Cancer. 2011 Jan;47(2):230-8. Epub 2010 Oct 11.

 

Weight-based strategy of dose administration in children using intravenous busulfan: clinical and pharmacokinetic results. 

Michel G, Valteau-Couanet D, Gentet JC, Esperou H, Socié G, Méchinaud F, Doz F, Neven B, Bertrand Y, Galambrun C, Demeocq F, Yakouben K, Bordigoni P, Frappaz D, Nguyen L, Vassal G. 

Pediatr Blood Cancer. 2012 Jan;58(1):90-7. doi: 10.1002/pbc.22959. Epub 2011 Jan 19.

 

Dose-finding designs in pediatric phase I clinical trials: comparison by simulations in a realistic timeline framework. 

Doussau A, Asselain B, Le Deley MC, Geoerger B, Doz F, Vassal G, Paoletti X. 

Contemp Clin Trials. 2012 Jul;33(4):657-65. Epub 2012 Apr 13.

 

2010

The role of the 'innovative therapies for children with cancer' (ITCC) European consortium.

Zwaan CM, Kearns P, Caron H, Verschuur A, Riccardi R, Boos J, Doz F, Geoerger B, Morland B, Vassal G; 'innovative therapies for children with cancer' European consortium.
Cancer Treat Rev. 2010 Jun;36(4):328-34. Epub 2010 Mar 15. Review.

 

[Specificity of paediatric oncology pharmacology].

André N, Leblond P, Verschuur A.
Bull Cancer. 2010 Feb;97(2):191-8. French.

 

2009

Target-driven exploratory study of imatinib mesylate in children with solid malignancies by the Innovative Therapies for Children with Cancer (ITCC) European Consortium.

Geoerger B, Morland B, Ndiaye A, Doz F, Kalifa G, Geoffray A, Pichon F, Frappaz D, Chatelut E, Opolon P, Hain S, Boderet F, Bosq J, Emile JF, Le Deley MC, Capdeville R, Vassal G; Innovative Therapies for Children with Cancer European Consortium.
Eur J Cancer. 2009 Sep;45(13):2342-51. Epub 2009 Apr 9.

 

Salvage treatment for children with refractory first or second relapse of acute myeloid leukaemia with gemtuzumab ozogamicin: results of a phase II study. 

Zwaan CMReinhardt DZimmerman M, Hasle H, Stary J, Stark B, Dworzak M, Creutzig U, Kaspers GJ; International BFM Study Group on Paediatric AML.
Br J Haematol. 2010 Mar;148(5):768-76. Epub 2009 Dec 8.
 
Toxicity assessment of molecularly targeted drugs incorporated into multiagent chemotherapy regimens for pediatric acute lymphocytic leukemia (ALL): review from an international consensus conference.

Horton TM, Sposto R, Brown P, Reynolds CP, Hunger SP, Winick NJ, Raetz EA, Carroll WL, Arceci RJ, Borowitz MJ, Gaynon PS, Gore L, Jeha S, Maurer BJ, Siegel SE, Biondi A, Kearns PR, Narendran A, Silverman LB, Smith MA, Zwaan CM, Whitlock JA; ALLNA 2008 Conference.
Pediatr Blood Cancer. 2010 Jul 1;54(7):872-8.

 

2008

Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia.

Porkka K, Koskenvesa P, Lundán T, Rimpiläinen J, Mustjoki S, Smykla R, Wild R, Luo R, Arnan M, Brethon B, Eccersley L, Hjorth-Hansen H, Höglund M, Klamova H, Knutsen H, Parikh S, Raffoux E, Gruber F, Brito-Babapulle F, Dombret H, Duarte RF, Elonen E, Paquette R, Zwaan CM, Lee FY.

Blood. 2008 Aug 15;112(4):1005-12. Epub 2008 May 13.

 

Prospective validation of a novel IV busulfan fixed dosing for paediatric patients to improve therapeutic AUC targeting without drug monitoring.

Vassal G, Michel G, Espérou H, Gentet JC, Valteau-Couanet D, Doz F, Mechinaud F, Galambrun C, Neven B, Zouabi H, Nguyen L, Puozzo C.
Cancer Chemother Pharmacol. 2008 Jan;61(1):113-23. Epub 2007 Mar 29.