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

2018 ◽  
Vol 100 ◽  
pp. 27-34 ◽  
Author(s):  
Lucas Moreno ◽  
Michela Casanova ◽  
Julia C. Chisholm ◽  
Pablo Berlanga ◽  
Pascal B. Chastagner ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumours ◽  
Children With Cancer ◽  
Paediatric Patients ◽  
Innovative Therapies

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

2012 ◽  
Vol 48 (3) ◽  
pp. 289-296 ◽  
Author(s):  
Birgit Geoerger ◽  
Edward J. Estlin ◽  
Isabelle Aerts ◽  
Pamela Kearns ◽  
Brenda Gibson ◽  
...  
Keyword(s):  
Phase I ◽  
Pharmacokinetic Study ◽  
Solid Tumours ◽  
Children With Cancer ◽  
Innovative Therapies

Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia: Results of the CA180-018 Phase I Dose-Escalation Study of the Innovative Therapies for Children With Cancer Consortium

2013 ◽  
Vol 31 (19) ◽  
pp. 2460-2468 ◽  
Author(s):  
C. Michel Zwaan ◽  
Carmelo Rizzari ◽  
Francoise Mechinaud ◽  
Donna L. Lancaster ◽  
Thomas Lehrnbecher ◽  
...  
Keyword(s):  
Phase I ◽  
Myeloid Leukemia ◽  
Philadelphia Chromosome ◽  
Cytogenetic Response ◽  
Pharmacokinetic Parameters ◽  
Molecular Response ◽  
Children With Cancer ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Innovative Therapies

Purpose Dasatinib is a potent BCR-ABL inhibitor with proven efficacy in adults with newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CP) and in imatinib-resistant/intolerant disease. This phase I study of the Innovative Therapies for Children with Cancer Consortium assessed dasatinib safety and efficacy in pediatric patients. Patients and Methods Escalating once-daily dasatinib doses (60 to 120 mg/m2) were administered to children (n = 58) with (i) imatinib-pretreated CML or Philadelphia chromosome (Ph)–positive acute lymhoblastic leukemia (ALL) and (ii) treatment-refractory Ph-negative ALL or acute myeloid leukemia (AML). Results Dasatinib safety and efficacy profiles compared favorably with those in adults. The most common drug-related nonhematologic adverse events were nausea (31%, all grades; 2%, grade 3 to 4), headache (22%, 3%), diarrhea (21%, 0%), and vomiting (17%, 2%). Of 17 patients with CML-CP, 14 (82%) achieved complete cytogenetic response (CCyR) and eight (47%) achieved major molecular response. After ≥ 24 months of follow-up, median complete hematologic response (CHR) and major cytogenetic response (MCyR) durations were not reached. Of 17 patients with advanced-phase CML or Ph-positive ALL, six (35%) achieved confirmed CHR and 11 (65%) achieved CCyR. Median MCyR duration was 4.6 months (95% CI, 2.1 to 17.4 months). No patient with Ph-negative ALL or AML responded. Dasatinib pediatric pharmacokinetic parameters were comparable with those in adult studies, showing rapid absorption (time to reach maximum concentration, 0.5 to 6.0 hours) and elimination (mean half-life, 3.0 to 4.4 hours). Conclusion Dasatinib 60 mg/m2 and 80 mg/m2 once-daily dosing were selected for phase II studies in children with Ph-positive leukemias.

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

2010 ◽  
Vol 13 (1) ◽  
pp. 109-118 ◽  
Author(s):  
B. Geoerger ◽  
D. Hargrave ◽  
F. Thomas ◽  
A. Ndiaye ◽  
D. Frappaz ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Phase I Study ◽  
Brainstem Glioma ◽  
Children With Cancer ◽  
Innovative Therapies
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