Phase I clinical trial - Pédiatrie Tumeurs solides

CRISP (IC 2017-08 / ITCC 053)
Pédiatrie Tumeurs solides
Ouvert depuis le: 09.17.2021
Site: Paris
Public cible
A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies.
Description de l'essai

In this study we therefore aim to evaluate combination therapy for different strata.;For stratum 1 we will combine crizotinib with vinblastine, based on earlier studies showing efficacy of vinblastine in the group of relapsed, ALK positive ALCL patients (stratum 1) and data on clinical activity with crizotinib.;À For stratum 2 a combination of crizotinib with temsirolimus will be given to patients with relapsed/refractory neuroblastoma or rhabdomyosarcoma with ALK or MET aberrations (stratum 2) for whom no standard treatment options are available.;À Children who have other ALK- ROS or MET positive tumors and who have no other treatment options or for whom surgery will lead to mutilation without prior tumor-shrinkage, will be enrolled in a separate stratum with crizotinib only (stratum 3).