A Phase I/II Study of Alectinib in Children and Adolescents with Solid Tumors or Central Nervous System Tumors Containing a Change in the ALK Gene

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Full Title

A Phase I/II, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors for whom Prior Treatment has Proven to be Ineffective or for whom there is no Satisfactory Treatment Available

Purpose

The purpose of this study is to find the highest dose of the drug alectinib that can be given safely in children and adolescents with solid tumors or brain and spinal cord cancers that persist after treatment and have a genetic change called an ALK gene fusion. With this gene fusion, the ALK gene attaches to part of another gene.

Alectinib blocks the activity of the ALK protein, which is found on the surface of cancer cells in tumors with an ALK fusion. Cancer cells need ALK proteins to survive and grow. When this protein is blocked, the cancer may stop growing or it may grow more slowly, and the cancer cells may shrink.

Alectinib is used to treat some adults with lung cancers that have an ALK fusion; its use in this study is investigational. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have a solid tumor or central nervous system (brain and/or spinal cord) cancer that continues to grow despite treatment.
  • Patients’ tumors must contain an ALK gene fusion.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients under age 18.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

21-330

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators