Abstract
Vincristine sulfate liposome injection (VSLI; Marqibo®) is an encapsulated preparation of standard vincristine in sphingomyelin/cholesterol liposomes. Clinical trials in adults have demonstrated safety, tolerability, and activity, leading to Food and Drug Administration (FDA) approval for adults with relapsed acute lymphoblastic leukemia (ALL). Pediatric experience with VSLI is limited. This single center, phase I dose escalation study examined the safety, toxicity, maximum tolerated dose, and pharmacokinetics of VSLI administered weekly to pediatric patients age <21 years with relapsed or chemotherapy-refractory solid tumors or leukemia. Twenty-one subjects were treated in total. Median age was 13.3 years (range 2-19). Fourteen subjects completed one 28-day cycle of therapy and five subjects completed more than one cycle. No subject experienced dose-limiting toxicity (DLT) at the first dose level (1.75 mg/m(2) /dose, dose range: 2-3.7 mg). At the second dose level (2.25 mg/m(2) /dose, dose range: 1.3-4.5 mg), one subject had transient dose-limiting grade 4 transaminase elevation, and this dose level was expanded with no additional DLT observed. The second dose level then opened to an expansion phase to evaluate activity in ALL...Continue Reading
References
Jan 1, 1981·Cancer Chemotherapy and Pharmacology·V S Sethi, J C Kimball
Oct 1, 1995·British Journal of Cancer·M S WebbL D Mayer
Oct 1, 1994·The Journal of Pediatrics·W R CromW E Evans
Jun 1, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J NachmanM E Trigg
Oct 27, 1998·Cancer Chemotherapy and Pharmacology·M S WebbM B Bally
Dec 16, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Bruce D ChesonUNKNOWN International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards
Dec 25, 2004·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Ellis GroningerSiebold de Graaf
Jan 24, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Bruce D ChesonUNKNOWN International Harmonization Project on Lymphoma
Jan 10, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jeffrey M SkolnikPeter C Adamson
Dec 23, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E A EisenhauerJ Verweij
Jun 19, 2009·Cancer·M A RodriguezUNKNOWN Marqibo Investigators
Aug 27, 2009·Cancer·Deborah A ThomasSusan O'Brien
Dec 22, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ching-Hon PuiMary V Relling
Mar 2, 2011·Pediatric Blood & Cancer·W Paul BowmanMichael J Borowitz
May 20, 2011·Cancer·Raveena RamphalRoss Pinkerton
May 13, 2011·Blood·Yousif MatloubPaul S Gaynon
Oct 24, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Richard B WomerAaron R Weiss
Nov 22, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Susan O'BrienHagop Kantarjian
Dec 6, 2012·Cancer Chemotherapy and Pharmacology·Jeffrey A Silverman, Steven R Deitcher
Feb 21, 2013·Pediatric Blood & Cancer·David R FreyerUNKNOWN COG Adolescent and Young Adult Oncology Discipline Committee
Jun 28, 2013·British Journal of Haematology·Fredrick HagemeisterFernando Cabanillas
Aug 3, 2013·Journal of Clinical Pharmacology·Jeffrey A SilvermanSteven R Deitcher
Dec 15, 2015·Investigational New Drugs·Nirali N ShahBrigitte C Widemann
Citations
Jul 28, 2016·Journal of Controlled Release : Official Journal of the Controlled Release Society·Andra-Sorina TatarSimion Astilean
Nov 12, 2016·Therapeutic Delivery·Mariacristina Gagliardi
Apr 28, 2017·Nanomedicine·Maurizio RoveriMichele Bernasconi
Sep 30, 2017·Drug Delivery·Yinan ZhongZhiyuan Zhong
Sep 22, 2018·Journal of Adolescent and Young Adult Oncology·Gary J SchillerDan Douer
Mar 19, 2019·Current Hematologic Malignancy Reports·Christine M McMahon, Selina M Luger
Jun 21, 2017·Journal of Translational Medicine·Michele GraciottiLana Kandalaft
Jan 25, 2020·American Journal of Clinical Oncology·Osama M Al-Quteimat
Dec 13, 2017·Clinical and Translational Medicine·Stephanie TranPrakash Rai
Feb 1, 2020·Recent Patents on Anti-cancer Drug Discovery·Hongyu TaoXiukun Lin
Apr 19, 2017·British Journal of Haematology·Claire A McClainEric S Schafer
Sep 14, 2018·Frontiers in Pharmacology·Fen YangJi Jiang
Sep 19, 2019·Expert Opinion on Drug Delivery·Ludger M Ickenstein, Patrick Garidel
Feb 12, 2020·Nanomaterials·Mohammad HoushmandClaudia Giachino
Jan 13, 2018·Frontiers in Bioengineering and Biotechnology·Raquel VinhasPedro V Baptista
Jun 27, 2020·Blood·Stephen P Hunger, Elizabeth A Raetz
Nov 4, 2017·Cancer Research·Christopher C MillsValerie B Sampson
Sep 9, 2019·Advanced Drug Delivery Reviews·Venkata K YellepeddiElizabeth Nance
Oct 7, 2019·Drug Discovery Today·Mohammad NorouziFatemeh Atyabi
Jan 30, 2021·Journal of Adolescent and Young Adult Oncology·Ajay GuptaSanjay P Ahuja
Nov 28, 2020·International Journal of Nanomedicine·Madhusmita Dhupal, Devasish Chowdhury
Feb 11, 2021·Cancers·Muhammad Abdur RahimHnin Ei Thu
Dec 16, 2018·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Zahra PayandehSaeed Khalil
Apr 27, 2021·Expert Opinion on Investigational Drugs·Julie M AsareStacy Cooper
Jun 3, 2021·Pharmaceutics·Noelia Nieto GonzálezElisabetta Gavini
Jun 11, 2021·Acta Biochimica Et Biophysica Sinica·Wang YaoJianhui Tian
Aug 3, 2018·ACS Nano·Carlos Rodríguez-NogalesMaría J Blanco-Prieto
Oct 17, 2021·Journal of Nanobiotechnology·Hong WangSanjun Shi
Dec 17, 2021·Biomacromolecules·Yifan ZhangZhiyuan Zhong