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

Nature Reviews. Clinical Oncology
Lucas MorenoInnovative Therapies for Children with Cancer (ITCC) Consortium

Abstract

In the past decade, the landscape of drug development in oncology has evolved dramatically; however, this paradigm shift remains to be adopted in early phase clinical trial designs for studies of molecularly targeted agents and immunotherapeutic agents in paediatric malignancies. In drug development, prioritization of drugs on the basis of knowledge of tumour biology, molecular 'drivers' of disease and a drug's mechanism of action, and therapeutic unmet needs are key elements; these aspects are relevant to early phase paediatric trials, in which molecular profiling is strongly encouraged. Herein, we describe the strategy of the Innovative Therapies for Children with Cancer (ITCC) Consortium, which advocates for the adoption of trial designs that enable uninterrupted patient recruitment, the extrapolation from studies in adults when possible, and the inclusion of expansion cohorts. If a drug has neither serious dose-related toxicities nor a narrow therapeutic index, then studies should generally be started at the adult recommended phase II dose corrected for body surface area, and act as dose-confirmation studies. The use of adaptive trial designs will enable drugs with promising activity to progress rapidly to randomized studie...Continue Reading

References

Sep 15, 1994·Statistics in Medicine·L G EnsignP F Thall
Aug 6, 1997·Journal of the National Cancer Institute·R SimonM C Christian
Mar 21, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·M SmithT Vietti
Dec 7, 2000·Journal of the National Cancer Institute·M Miller
Mar 10, 2001·Clinical Pharmacology and Therapeutics·UNKNOWN Biomarkers Definitions Working Group.
Mar 29, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·John R JohnsonRichard Pazdur
Sep 19, 2003·The New England Journal of Medicine·Gregory L KearnsRalph E Kauffman
Sep 2, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Najat C DawUNKNOWN Children's Oncology Group
Nov 19, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Debra P LeePeter C Adamson
Dec 31, 2005·The New England Journal of Medicine·Deborah A ZarinNicholas C Ide
Jan 31, 2006·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Fabio LeviCarlo La Vecchia
Jun 6, 2006·The Lancet Oncology·Roderick SkinnerUNKNOWN UK Children's Cancer Study Group Late Effects Group
Jun 19, 2007·Statistics in Medicine·Sin-Ho Jung
Dec 18, 2007·Lancet·Tammy F ChuMing Hui Chen
Jan 10, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jeffrey M SkolnikPeter C Adamson
Jan 19, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Julia L Glade BenderUNKNOWN Children's Oncology Group Study
Mar 18, 2008·Statistics in Medicine·Beat NeuenschwanderThomas Gsponer
Apr 30, 2009·British Journal of Cancer·S Postel-VinayS Kaye
May 8, 2009·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Gilles Vassal
Sep 23, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Tanya M TrippettLia Gore
Feb 11, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Jane Carr-WilkinsonDeborah A Tweddle
Mar 17, 2010·Cancer Treatment Reviews·C Michel ZwaanUNKNOWN 'innovative therapies for children with cancer' European consortium
Jun 11, 2010·Nature Reviews. Cancer·Timothy A YapJohann S de Bono
Aug 19, 2010·Italian Journal of Pediatrics·Francesca RocchiPaolo Rossi
Oct 1, 2010·The New England Journal of Medicine·Alice L YuUNKNOWN Children's Oncology Group
Oct 27, 2010·Neuro-oncology·Birgit GeoergerUNKNOWN ITCC (Innovative Therapies for Children with Cancer) European Consortium
Mar 8, 2011·Cell·Douglas Hanahan, Robert A Weinberg
May 26, 2011·Clinical Trials : Journal of the Society for Clinical Trials·Lili ZhaoThomas M Braun
Jun 22, 2011·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Steven G DuboisSusan M Blaney
Oct 26, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Heribert JuergensAntonio Gualberto
Dec 21, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Suman MalempatiSusan M Blaney
Sep 1, 2012·Nature Reviews. Drug Discovery·Patrick Y Muller, Mark N Milton
Oct 12, 2012·Nature Reviews. Cancer·Robin E Norris, Peter C Adamson
Nov 22, 2012·Journal of the National Cancer Institute·Sachin GuptaPatricia LoRusso
Jan 19, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Gilles VassalBruce Morland
Feb 26, 2013·The Lancet Oncology·Kathy Pritchard-Jones, Richard Sullivan
Feb 26, 2013·The Lancet Oncology·Gilles VassalPeter C Adamson
Mar 30, 2013·Science·Bert VogelsteinKenneth W Kinzler
Apr 2, 2013·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Xavier PaolettiChristophe Le Tourneau

❮ Previous
Next ❯

Citations

Dec 1, 2017·Current Opinion in Pediatrics·Suzanne J ForrestKatherine A Janeway
Aug 25, 2017·Clinical Pharmacology and Therapeutics·Clinton F Stewart, Giles W Robinson
Dec 19, 2018·Journal of Clinical Pharmacology·Mohamad ShebleyPatrick J Marroum
Jan 27, 2018·Cell Death & Disease·Mike-Andrew WesthoffKlaus-Michael Debatin
Sep 21, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Caroline RossoniXavier Paoletti
Jan 16, 2020·Cancer Metastasis Reviews·Teresa de RojasLucas Moreno
Dec 14, 2019·Cancer Metastasis Reviews·Patricia KattnerKlaus-Michael Debatin
Mar 7, 2020·British Journal of Haematology·Maria L MoletiRobin Foà
Feb 6, 2020·Clinical Pharmacology and Therapeutics·Julie M JanssenAlwin D R Huitema
Dec 4, 2019·Current Opinion in Pediatrics·Kevin CampbellSteven G DuBois
Sep 5, 2020·Pediatric Blood & Cancer·Jaclynne H NaderSteven G DuBois
Feb 8, 2019·British Journal of Haematology·Mitchell S Cairo, Auke Beishuizen
Mar 16, 2019·Science·Steven G DuBoisKatherine A Janeway
Jul 14, 2019·Nature Reviews. Cancer·David T W JonesStefan M Pfister
Dec 27, 2017·Clinical Pharmacology and Therapeutics·Jeffrey S BarrettUNKNOWN IQ consortium - CPLG Pediatric Working Group
Sep 12, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Mark W KieranJames A Whitlock
Nov 1, 2020·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Alba Rubio-San-SimónFrancisco Bautista
Oct 30, 2020·Archives of Disease in Childhood·Steven HirschfeldJenny M Kindblom
Oct 28, 2020·British Journal of Cancer·Carolina BernauerJanet M Shipley
Mar 23, 2021·Journal of Neuropathology and Experimental Neurology·Nathan A DahlRajeev Vibhakar
Jun 9, 2021·Pediatric Research·Athimalaipet V RamananUNKNOWN c4c Learning from COVID-19 Group
Jun 23, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Birgit GeoergerLynley V Marshall
Sep 25, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Amy B Hont, Catherine M Bollard

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Cancer Treatment Reviews
Christian Michel Zwaan'innovative therapies for children with cancer' European consortium
Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico
F BautistaLucas Moreno
European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
Gilles VassalHeinz Zwierzina
Anales de pediatría : publicación oficial de la Asociación Española de Pediatría (A.E.P.)
Francisco BautistaSociedad Española de Hematología y Oncología Pediátrica (SEHOP) and the New Drug Development Group in Pediatric Oncology
Nature Reviews. Drug Discovery
Ernest C Borden, Afshin Dowlati
© 2022 Meta ULC. All rights reserved