A Phase I/II Study of Crizotinib for Recurrent or Refractory Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma and a Phase I Study of Crizotinib for Recurrent or Refractory Neuroblastoma : Study Protocol for a Multicenter Single-arm Open-label Trial

Acta Med Okayama. 2018 Aug;72(4):431-436. doi: 10.18926/AMO/56184.

Abstract

Crizotinib is an inhibitor of multiple tyrosine kinases, including the anaplastic lymphoma kinase (ALK). Responses to crizotinib have also been reported in patients with ALK-positive anaplastic large-cell lymphoma (ALCL) and solid tumors with ALK-mutation, including neuroblastoma. Optimal treatment for patients with recurrent or refractory ALK-positive ALCL and neuroblastoma has not been established. There is a need to develop new drugs for these patients. The objectives of this trial are to evaluate the tolerability and safety of crizotinib in Japanese patients with recurrent/refractory ALK-positive ALCL or neuroblastoma (phase I) and its efficacy in recurrent/refractory ALK-positive ALCL (phase II).

Keywords: anaplastic large cell lymphoma; crizotinib; neuroblastoma; recurrent; refractory.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Anaplastic Lymphoma Kinase / analysis*
  • Antineoplastic Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Clinical Trials, Phase I as Topic*
  • Clinical Trials, Phase II as Topic*
  • Crizotinib / adverse effects
  • Crizotinib / therapeutic use*
  • Humans
  • Infant
  • Lymphoma, Large-Cell, Anaplastic / drug therapy*
  • Lymphoma, Large-Cell, Anaplastic / enzymology
  • Multicenter Studies as Topic
  • Neuroblastoma / drug therapy*
  • Protein Kinase Inhibitors / therapeutic use*
  • Recurrence

Substances

  • Antineoplastic Agents
  • Protein Kinase Inhibitors
  • Crizotinib
  • Anaplastic Lymphoma Kinase